Willingness Of Pregnant Women Research Articles

Pregnant women\u2019s experiences and perceptions of participating in the EVERREST prospective study; a qualitative study

BackgroundThe EVERREST Prospective Study is a multicentre observational cohort study of pregnancies affected by severe early-onset fetal growth restriction. The study recruits women with singleton pregnancies where the estimated fetal weight is less than the 3rd centile and below 600 g, between 20 + 0 and 26 + 6 weeks of pregnancy, in the absence of a known chromosomal, structural or infective cause.MethodThe reported study was retrospective descriptive qualitative interview study of women who had participated in the EVERREST Prospective Study. The aim of this study was to explore the experiences and perceptions of pregnant women taking part in research during a pregnancy affected by severe early-onset fetal growth restriction. Audio-recorded semi-structured telephone interviews were conducted with a purposive sample of 12 women, at least 1 year after delivery of their baby. Two of these pregnancies had ended in stillbirth and one in neonatal death, reflecting the outcomes seen in the EVERREST Prospective Study. Participants gave informed consent, were 16 years or older and were interviewed in English. A topic guide was used to ensure a consistent approach. Questions focused on pregnancy experiences, involvement with the EVERREST study and potential involvement in future research. Recordings were transcribed verbatim for thematic analysis using NVivo10.ResultsFour broad themes were identified; ‘before joining the EVERREST Prospective Study’, ‘participating in research’, ‘information and support’ and ‘looking back and looking forwards’. Each broad theme incorporated several subthemes. All participants recalled their reaction to being told their baby was smaller than expected. The way this news was given had a lasting impact. A range of benefits of participation in the EVERREST Prospective Study were described and the participants were positive about the way it was conducted. As a consequence, they were receptive to participating in future research. However, the findings suggest that research teams should be sensitive when approaching families at a difficult time or when they are already participating in other research.ConclusionsThis study highlights the willingness of pregnant women to participate in research and identifies strategies for researchers to engage participants.

Maternal body weight and diet management system.

BackgroundBody weight control is a significant issue to pregnant women. Overweight or underweight not only affects the normal growth of the fetus but also results in health impacts for pregnant women. Currently, some mobile applications which have released to stress how to achieve the purpose of weight control are not suitable for pregnant women. To design an appropriate mobile application of body weight control for pregnant women, a multidiscipline team collaborated.ObjectiveThis study proposed a mobile application approach to assist women to maintain an ideal weight control during their pregnancy. In addition, the usefulness of the application was evaluated among pregnancy women.MethodsFirstly, the guidance of weight and diet management for pregnant women were obtained from textbooks and professional healthcare providers including nurses and nutritionists. Secondly, the researcher considered aspects of Human-Computer Interaction and theories of information technology behavior to design the mobile application. Finally, 52 pregnant women were recruited to test the prototype, which is a mobile application available on different devices with browsers.ConclusionsCompared with other similar types of body weight and diet management mobile applications, the proposed application offers several characteristics to increase pregnant women's willingness to use it.

Contributing factors of pregnant women\u2019s beliefs towards mode of delivery: a cross-sectional study from Iran

sBackgroundDelivery is a critical event in every woman’s life. Under some medical conditions, women sometimes undergo a cesarean section to save the life of themselves and their infant. Understanding the factors associated with choosing the type of delivery leads to more effective health interventions and the promotion of maternal and newborn health. The aim of this study is to determine contributing factors in pregnant women’s beliefs toward the mode of delivery in a sample of women referring to Hojatieh Hospital in Isfahan, Iran.MethodsThis cross-sectional study was conducted in September 2016 on 200 pregnant women (gestational age 30–37 weeks) referred to Hojatieh Hospital in Isfahan, Iran. The inclusion criteria of this study included healthy pregnancy and having no known cases (heart, pulmonary, and renal disease) and pregnancy complications (spotting, bleeding, headache, blurred vision), and willingness of pregnant women to complete the questionnaire. Data were collected through an eight-part questionnaire consisting of demographic factors, delivery intention, knowledge, perceived self-efficacy, attitude, perceived social, and private support in the presence of the researcher and the outcome of delivery were asked 2 weeks after the due date of delivery during a telephone call. Data were analyzed using SPSS16 software, independent t-test, chi-square, and logistic regression.ResultsThere was no significant differences between the mean scores of knowledge and private social support among individuals with two types of delivery (P > 0.05), but the mean scores of perceived self-efficacy and public social support in women who gave birth normal were significantly higher than those of women who gave birth by cesarean section (P < 0.05).ConclusionThe findings of this study showed that attitude and perceived self-efficacy were the most important predictors of delivery mode. Therefore, education based on the items included in these factors might be useful for choosing the delivery mode. The results might be used in evidence based midwifery practices in low and middle income countries to promote normal delivery and perhaps maternal health index.

Factors associated with acceptance of provider-initiated HIV testing and counseling among pregnant women in Ethiopia.

IntroductionThe global human immunodeficiency virus (HIV) epidemic disproportionately affects sub-Saharan African countries, including Ethiopia. Provider-initiated HIV testing and counseling (PITC) is a tool to identify HIV-positive pregnant women and an effective treatment and prevention strategy. However, its success depends upon the willingness of pregnant women to accept HIV testing.ObjectivesTo describe the level of acceptance of PITC and associated factors among pregnant women attending 8 antenatal care clinics in Adama, Ethiopia.MethodsTrained nursing students and employees from an HIV clinic conducted face-to-face structured interviews in private offices at the clinics from August to September, 2016.ResultsAmong the 441 respondents, 309 (70.1%) accepted PITC. Women with more antenatal care visits (odds ratio [OR] =2.59, 95% CI: 1.01–6.63), reported better quality of the PITC service (OR =1.91, 95% CI: 1.19–3.08), and higher level of knowledge on mother-to-child transmission (OR =1.82, 95% CI: 1.03–3.20), were more likely to accept PITC, while women who were older in age (OR =0.37, 95% CI: 0.19–0.74) and perceived negative attitudes from their partners toward HIV-positive results (OR =0.31, 95% CI: 0.10–0.94) were less likely to accept the PITC service.ConclusionAbout one-third of pregnant women are not willing to accept PITC. When designing intervention program to improve the acceptance of PITC, we should take into consideration the personal factors, HIV-related knowledge, and attitude of women as well as institutional factors.

Attitudes towards Zika screening and vaccination acceptability among pregnant women in Malaysia.

The aim of this study was to examine the willingness of pregnant women to have prenatal screening for the Zika virus (ZIKV). Secondly, the study also assessed the acceptability of a hypothetical Zika vaccination and its association with the health belief model (HBM) constructs. A cross-sectional study was conducted from 4th October to 11th November 2016, among pregnant women who attended antenatal care at the University Malaya Medical Centre (UMMC), Kuala Lumpur, Malaysia. The majority (81.8%) was willing to be tested for ZIKV and 78% felt that their spouse would be willing to be tested for ZIKV. A total of 94% expressed a willingness to receive a Zika vaccination if available. The participants expressed high perceived benefits of a ZIKV vaccination. Although many have a high perception of the severity of ZIKV, the proportion with a strong perception of their susceptibility to ZIKV was low. In the multivariate analysis of all the HBM constructs, cue-to-action, namely physician recommendation (odds ratio [OR]=2.288; 95% confidence interval [CI] 1.093-4.793) and recommendation from friends or relatives (OR=4.030; 95% CI 1.694-9.587), were significantly associated with a willingness to be vaccinated against ZIKV. The favourable response to a Zika vaccination implies that more research attention has to be given to develop a vaccine against ZIKV. Should the vaccine be available in the future, publicity and healthcare providers would play a vital role in ensuring vaccine uptake among pregnant women.

The Formulation of High-Calorie and Rich-Fe Biscuits for Pregnant Women with Chronic Energy Malnutrition

Supplementary food distribution for pregnant women still depends on the local policy. This program is funded using Health Operational Funds and distributed in form of milk, eggs, raw materials such as green beans and others. The field constraints of this program were acceptability and willingness of pregnant women to process the raw materials. This study aims to address the problems of providing supplementary food for pregnant women who suffer from chronic energy malnutrition and anemia by making the formulation of high protein biscuits and Fe using soybean flour substitution catfish eggs and flour as a source of protein and Fe. Biscuits produced is expected to be one of the snacks and nutritions for women who suffer from chronic energy deficeincy. The ingredients were flour, fish powder, soy flour, eggs, milk powder, sugar, and maize flour. The method used was pure experimental approach completely randomized design with three times repetition. The formulation of the biscuits proportion between fish and soy flour as much as 2:1, 1:1, and 1:2. Proximate test shows that the proportion of fish and soy flour 1:2 has the highest energy value (496.81 kcal) with a value of 17.74% protein. Organoleptic test indicates that the most favorable taste and tekstur was the formulation with the proportion of fish flour and soy flour 1:2. The formulation of high protein and Fe biscuits for women with chronic energy malnutrition and anemia in Boyolali favoured by third trisemester pregnant women is the one with the proportion of 1:2.

The Formulation of High-Calorie and Rich-Fe Biscuits for Pregnant Women with Chronic Energy Malnutrition

Supplementary food distribution for pregnant women still depends on the local policy. This program is funded using Health Operational Funds and distributed in form of milk, eggs, raw materials such as green beans and others. The field constraints of this program were acceptability and willingness of pregnant women to process the raw materials. This study aims to address the problems of providing supplementary food for pregnant women who suffer from chronic energy malnutrition and anemia by making the formulation of high protein biscuits and Fe using soybean flour substitution catfish eggs and flour as a source of protein and Fe. Biscuits produced is expected to be one of the snacks and nutritions for women who suffer from chronic energy deficeincy. The ingredients were flour, fish powder, soy flour, eggs, milk powder, sugar, and maize flour. The method used was pure experimental approach completely randomized design with three times repetition. The formulation of the biscuits proportion between fish and soy flour as much as 2:1, 1:1, and 1:2. Proximate test shows that the proportion of fish and soy flour 1:2 has the highest energy value (496.81 kcal) with a value of 17.74% protein. Organoleptic test indicates that the most favorable taste and tekstur was the formulation with the proportion of fish flour and soy flour 1:2. The formulation of high protein and Fe biscuits for women with chronic energy malnutrition and anemia in Boyolali favoured by third trisemester pregnant women is the one with the proportion of 1:2.

P-B20 Evaluation of the feasibility of incorporating HPV DNA- based cervical cancer screening into routine antenatal care in Nigeria

Introduction: Persistent high-risk HPV infection is a necessary cause of cervical cancer. HPV DNA testing is now the primary WHO recommended approach to cervical cancer screening. Cervical cancer screening uptake remains abysmally low in Nigeria and in other low and middle income countries (LMIC). Antenatal care-based HPV DNA testing is a largely unexplored strategy to increase uptake of cervical cancer screening in LMIC. Up to 70% of women in Africa attend ANC at least once during their pregnancy and many attend at least twice. We evaluated the acceptability of HPV DNA testing as part of routine antenatal care among pregnant women and healthcare workers in Nigeria. Methodology: We conducted focus group discussions (FGD) among pregnant women and Key Informant Interviews among healthcare providers at a hospital facility in Abuja, Nigeria. A total of 24 muslim and christian pregnant women were invited for the focus groups and each group comprised of 6–10 participants. Obstetric/Gynaecologists (O&G) and ANC nurses were interviewed. We used content analysis method for data analysis. Coding sheets were developed to summarize findings. Results: Our study showed fair level of knowledge and awareness of cervical cancer and cervical cancer screening among the pregnant women, however, practice was poor, as none of the women had ever been screened for cervical cancer. Lack of awareness about cervical cancer screening, costs, and fear of screening outcome were commonly cited as barriers to uptake. The nurses interviewed expressed reservations about the willingness of pregnant women to participate in screening but there was a high level of willingness among the pregnant women to be screened during the ANC period. Their religion and parity played no role in determining the acceptance of HPV DNA testing in ANC. The O&G specialists expressed full support for integrating HPV DNA testing into routine ANC services. Conclusions: Our results show the need to explore more innovative public health interventions to reduce cervical cancer burden in LMIC.

Prenatal recruitment of participants for a birth cohort study including cord blood collection: results of a feasibility study in Bremen, Germany.

Background: Prospective birth cohort studies comprising follow up of children from pregnancy or birth over a long period of time, and collecting various biological samples at different times through the life-course offer a promising approach to enhance etiologic knowledge of various diseases. Especially for those where early lifetime exposures and conditions are thought to play an important role. The collection and storage of biological samples is a critical component in epidemiological studies, notably for research regarding prenatal exposures to various environmental factors as well as for DNA extraction. Our feasibility study for a birth cohort within the scope of etiology of childhood leukemia with prospective sampling of mothers and their future newborns aimed to investigate the willingness of pregnant women to participate in a birth cohort study involving collection of blood and umbilical cord blood samples. The overall aim was to develop practice-based research recommendations for a possible German birth cohort study. Methods: The study was conducted in Bremen, Germany, between January 2012 and March 2013. Pregnant women were eligible for recruitment if (i) their expected date of delivery was during the study recruitment phase (September 2012–February 2013), (ii) they planned to give birth at the cooperating hospital’s obstetric unit and (iii) their knowledge of the German language was sufficient to understand study materials, details of participation and to fill out the prenatal self-administered questionnaire. Maternal blood and umbilical cord blood samples to be used for later research activities were collected and stored at a stem cell bank already collaborating with the hospital. 22 primary care gynecologists were invited to enroll pregnant women for the study and cooperation with one hospital was established. Expectant women were recruited during the last trimester of pregnancy, either during one of their prenatal care visits at their primary care gynecologist or later on in hospital by the attending obstetricians or project staff.Results: Of the 22 invited primary care gynecologists requested to enroll pregnant women for the study, 8 gynecologists actually collaborated. A total of 200 eligible women were invited to participate in the study, 48 (24%) of whom agreed. 34 women were enrolled by primary care gynecologists, with one gynecologist enrolling 26 women. Twelve of 14 women recruited via hospitals were enrolled by study staff. A total of 41 women consented to the collection of umbilical cord blood and maternal blood samples, and samples could be stored for 54% of them. Reason for non-participation were the uncertainty whether or not the full study would be conducted and the fact that the participants were not willing to decide for their children whether or not genetic information (cord blood) can be stored for research purposes.Conclusion: Enrolling parents in a birth cohort study that includes biosampling is a challenge, but participation can be improved through close collaboration with primary care gynecologists and maternity hospitals. Cord blood collection may impede participation, especially when maternity hospitals offer an alternative option for cord blood donation.

Sociodemographic predictors of acceptance of voluntary HIV testing among pregnant women in a large maternity hospital, Omdurman, Sudan.

This study aimed to determine the sociodemographic predictors of willingness of pregnant women in Sudan to accept HIV testing. A random sample of 500 pregnant women attending antenatal care clinics in Omdurman maternity hospital in 2010 were interviewed. Significant predictors of women's tendency to accept HIV testing were: age < 30 years (OR 3.5, 95% CI: 2.2-5.8), primigravida (OR 1.5, 95% CI: 1.0-2.3), better education level (OR 3.4, 95% CI: 1.7-6.7), owning a radio (OR 2.1, 95% CI: 1.3-3.4), in employment (OR 2.5, 95% CI: 1.2-5.0) and ≥ 2 antenatal care visits (OR 1.9, 95% CI: 1.2-2.9). Husband's age ≥ 35 years (OR 3.2, 95% CI: 2.0-5.2) and Christian faith (OR 3.8, 95% CI: 1.4-10.7) were significant variables, although with a wide margin of confidence. These predictors should be considered in strategies to increase the acceptance and use of HIV testing and counselling services.

Internet Use and Access Among Pregnant Women via Computer and Mobile Phone: Implications for Delivery of Perinatal Care.

BackgroundThe use of Internet-based behavioral programs may be an efficient, flexible method to enhance prenatal care and improve pregnancy outcomes. There are few data about access to, and use of, the Internet via computers and mobile phones among pregnant women.ObjectiveWe describe pregnant women’s access to, and use of, computers, mobile phones, and computer technologies (eg, Internet, blogs, chat rooms) in a southern United States population. We describe the willingness of pregnant women to participate in Internet-supported weight-loss interventions delivered via computers or mobile phones.MethodsWe conducted a cross-sectional survey among 100 pregnant women at a tertiary referral center ultrasound clinic in the southeast United States. Data were analyzed using Stata version 10 (StataCorp) and R (R Core Team 2013). Means and frequency procedures were used to describe demographic characteristics, access to computers and mobile phones, and use of specific Internet modalities. Chi-square testing was used to determine whether there were differences in technology access and Internet modality use according to age, race/ethnicity, income, or children in the home. The Fisher’s exact test was used to describe preferences to participate in Internet-based postpartum weight-loss interventions via computer versus mobile phone. Logistic regression was used to determine demographic characteristics associated with these preferences.ResultsThe study sample was 61.0% white, 26.0% black, 6.0% Hispanic, and 7.0% Asian with a mean age of 31.0 (SD 5.1). Most participants had access to a computer (89/100, 89.0%) or mobile phone (88/100, 88.0%) for at least 8 hours per week. Access remained high (>74%) across age groups, racial/ethnic groups, income levels, and number of children in the home. Internet/Web (94/100, 94.0%), email (90/100, 90.0%), and Facebook (50/100, 50.0%) were the most commonly used Internet technologies. Women aged less than 30 years were more likely to report use of Twitter and chat rooms compared to women 30 years of age or older. Of the participants, 82.0% (82/100) were fairly willing or very willing to participate in postpartum lifestyle intervention. Of the participants, 83.0% (83/100) were fairly willing or very willing to participate in an Internet intervention delivered via computer, while only 49.0% (49/100) were fairly willing or very willing to do so via mobile phone technology. Older women and women with children tended to be less likely to desire a mobile phone-based program.ConclusionsThere is broad access and use of computer and mobile phone technology among southern US pregnant women with varied demographic characteristics. Pregnant women are willing to participate in Internet-supported perinatal interventions. Our findings can inform the development of computer- and mobile phone-based approaches for the delivery of clinical and educational interventions.

Umbilical Cord Blood Donation and Banking: Awareness Among Pregnant Women, in Makurdi, Nigeria

Background: Umbilical Cord Blood (UCB) donation and banking is transforming transfusion medicine around the world. There is a dearth of data on awareness and perception of this practice among pregnant women in our setting. Objectives: We sought to determine the awareness of UCB donation and banking by pregnant women in Makurdi, North central, Nigeria. Methods: With the use of structured questionnaire, information on socio-demography, awareness of UCB donation and banking, and sources of information on UCB were collected from 302 pregnant women attending the antenatal clinic of Benue State University Teaching Hospital, Makurdi. Data generated was analyzed with Statistical Package for Social Sciences version 19. Results: Majority of the respondents was aged 25-30 years (52.0%). They were predominantly Tiv (84.2%), Civil servants (45.3%), Christians (95.1%), and 62.4% had tertiary education. Nineteen percent of the women were aware of UCB donation and banking. The sources of information on UCB were hospital (30.2%), media (39.0%), friends, (24.0%), the internet (6.8%). Awareness of UCB as an alternative to adult blood transfusion was not influenced by socio-demographic characteristics of the respondents. Conclusion: Awareness of UCB donation and banking by pregnant women in Makurdi is low. The major source of information on UCB was from the media. Public awareness programs will have to be instituted especially in the health facilities. These programs if properly implemented will improve the willingness of pregnant women to donate UCB and also enhance the acceptance of UCB as a treatment option.

Willingness of pregnant women to participate in a birth cohort study in China

ObjectiveTo determine the willingness of pregnant women in Guangzhou, China, to participate in a large-scale birth cohort study. MethodsA cross-sectional survey was conducted of 526 pregnant women who attended their first prenatal class at Guangzhou Women and Children’s Medical Center, Guangzhou, China, between September 21 and November 15, 2011. Information on demographic characteristics, willingness to participate, and preferences regarding collection procedures and incentives were analyzed. ResultsIn all, 47.9% of the women were willing to participate in a birth cohort study, whereas 23.0% refused and 29.1% were unsure. The majority of the women willing to participate (95.2%–98.4%) accepted the use of non-invasive data collection methods except for stool collection, and 85.9% would allow their offspring to participate in long-term follow-up. Willingness to participate rose to 85.2% when non-monetary incentives were offered. The most popular incentive was assessment of child development. ConclusionThe willingness of pregnant Chinese women to participate in long-term observational research was similar to that reported in high-income countries. Non-monetary incentives improved their level of willingness, a finding that might inform future maternal and child health research in low- and middle-income countries.

Willingness to Participate in Research during Pregnancy

This paper examines the willingness of pregnant women to participate in research on health. We investigate attitudes toward multiple methods of data collection including survey and biomarker data collection. Complete interviews were obtained from a sample of 90 pregnant women in a matched control-comparison study of patients receiving prenatal care in private practice and clinic settings. Women experiencing prenatal care at a clinic reported less willingness to participate in research than women experiencing prenatal care at a private practice. Women who deemed "contributing to science", "learning about pregnancy health", and "helping future patients" as important motivations for participating in research were more likely to express willingness to participate in a study. African American women reported less willingness to answer questions in a survey compared to white women. The results suggest that motivational factors should be integrated into the design of a study of pregnant women to encourage participation.

Willingness of Pregnant Women in Benin City Nigeria to Donate Placenta Cord Blood for Stem Cell Transplantation

Stem Cell Transplantation has become an approved curative therapy for malignant and non-malignant disorders. Cord blood is a recommended source of Stem cell for Haematopoietic Stem Cell Transplantation (HSCT). However the method of collection, maternal and placenta factors have been shown to influence the quantity and quality of the cord blood. A total of 302 pregnant women, attending the Ante-Natal Clinic from June to August 2010 at the University of Benin Teaching Hospital (UBTH) were assessed for willingness to donate placenta cord blood for HSCT The results revealed that most of the women were mainly of age group 20-29yrs (53.2%), parity of 1 to 2 (59.6%), have tertiary education (57.6%) and were Christians (95.4%). However 212 (70.2%) of the pregnant women were willing to donate placenta cord blood. Reasons for those not willing to donate placenta cord blood were mainly that of fear of losing their child�s destiny (Placenta)with a figure of 20(22.2%), that it is a strange idea 16(17.8%), religious and traditional beliefs 14(15.6%)/8(8.9%) respectively. As part of the UBTH policy women routinely leave their placenta behind to be discarded by the hospital. Those who would prefer to take their placenta home were 32(10.6%) and 24(75%) of these women would rather bury their placenta in their compounds. The other 8(25%), would discard it in the dust bin. There is need to educate and reassure pregnant women in Nigeria to donate placenta cord blood, which hitherto is a biological waste. Cord blood in the future could be an important source of stem cells for HSCT for the purpose of initiating blood banking in Nigeria. Keywords: Placenta Cord Blood, Willingness to Donate, Stem Cell Transplantation. class

Willingness of pregnant women to vaccinate themselves and their newborns with the HPV vaccine

ObjectiveTo evaluate the willingness of pregnant women to accept the HPV vaccine for their newborns as well as themselves. MethodsAn 18-item questionnaire was distributed to antepartum women. Demographic data about the respondent's current pregnancy and her knowledge of HPV and the HPV vaccine was collected. Information about the respondent's HPV and HPV vaccine status as well as her acceptance of the vaccine for herself during pregnancy and her newborn son and/or daughter after delivery was also collected. ResultsThree hundred surveys were completed and available for review. Only 6 respondents (2%) had received the HPV vaccine. Despite the small group of patients who had previously been vaccinated, 112 respondents (37.3%) stated that they would receive the HPV vaccine during pregnancy if recommended by an obstetrician. 99 respondents (33%) stated that they would vaccinate their newborn female infant and 83 (27.7%) stated would vaccinate their male infants. ConclusionProviding the HPV vaccine to pregnant women as well as newborns could be an important way to increase the patient population who is protected against HPV. A percentage of pregnant women are willing to accept the vaccine for themselves and their newborns.

HSV Serologic Testing for Pregnant Women: Willingness to Be Tested and Factors Affecting Testing

Objective. This prospective study was undertaken to evaluate pregnant women's willingness to undergo HSV type-specific serologic testing and factors affecting willingness in an obstetrics/gynecology ambulatory unit. Methods. At prenatal Visit 1, pregnant women (n = 303) with no history of HSV-2 were tested for HSV-1/HSV-2 before and after they received counseling on genital and neonatal herpes. Results. In both the Unwilling Subgroup and the group that changed from being willing to being unwilling, the most common reasons for choosing not to be tested were not being at risk for genital herpes, being tested is too personal, and concern about what will be done with the results. Of the 134 participants in the Willing/Tested Subgroup, 27 (20%) were HSV-2 seropositive and 81 (60%) were HSV-1 seropositive. Conclusions. These results support the feasibility of HSV serologic testing and counseling in pregnant women.

Willingness of pregnant women and clinicians to participate in a hypothetical randomised controlled trial comparing vaginal delivery and elective caesarean section

Elective caesarean section is controversial in the absence of compelling evidence of the relative benefits and harms compared with vaginal delivery. A randomised trial of the two procedures to compare outcomes for women and babies would provide the best quality scientific evidence to confirm this debate but it is not known whether such a trial would be feasible. To ascertain the proportion of primiparas and clinicians who would participate in a hypothetical randomised controlled trial comparing vaginal delivery with elective caesarean section. Pregnant women (mean 22 weeks gestation) recruited from public and private antenatal clinics at a major tertiary referral centre were interviewed to ascertain their willingness to participate in a hypothetical randomised controlled trial. A self-administered questionnaire was mailed to midwives, obstetricians, urogynaecologists and colorectal surgeons, and results between groups were compared. One hundred pregnant women, 84 midwives, 166 obstetricians, 12 urogynaecologists and 87 colorectal surgeons participated. Only 14% (95% confidence interval (CI), 8-22) of pregnant women and 31% (95% CI, 26-36) of clinicians indicated that they would participate in a randomised controlled trial. A randomised controlled trial comparing vaginal delivery and elective caesarean section may not be feasible due to low levels of willingness to participate, particularly among pregnant women.

Participation of pregnant women in clinical trials: will they participate and why?

The objective of this study is to investigate the willingness of pregnant women to participate in a randomized placebo-controlled clinical trial, and to explore the determinants of their decision making. Cross-sectional survey with semistructured interview and thematic content analysis of pregnant women in a tiertiary care obstetric outpatient clinic. Among the 50 women surveyed, 37 (74%; 95% confidence interval, 60-85%) indicated that they would be willing to participate in a randomized placebo-controlled trial of an injectable medicine given throughout pregnancy, while 5/50 (10%; 95% confidence interval, 3-22%) would decline to participate. Potential benefit to the health of the fetus was ranked as the most important determinant for willingness to participate (68%), followed by benefit to personal health (27%), and altruism (5%). A majority of pregnant women would be willing to participate in a randomized placebo-controlled clinical trial. Pregnant women appear to be willing to accept risks to themselves, if there is a chance that participation in a clinical trial would help their pregnancy and improve their baby's health.