Recruitment Of Pregnant Women Research Articles

Obstetricians’ engagement for successful recruitment of participants in a randomized controlled trial promoting healthful fish consumption during pregnancy

BACKGROUND AND AIM: Human biomonitoring trials depend on the voluntary participation of citizens, who donate biological samples and personal information related to the investigated chemical exposures. Pregnant women are vulnerable to exposure to mercury, a potent developmental neurotoxicant. In Europe, the primary source of exposure to mercury relates to fish consumption. At the same time, fish consumption during pregnancy provides essential nutrients for optimal fetal brain and eye development. The benefits can outweigh the risks if suitable dietary advice is provided during pregnancy. METHODS: Cyprus, a small coastal Southeastern European country, used national data of fish consumption and mercury occurrence in fish to develop the first ever recommendations for Cypriot pregnant women. These are tested in the European “HBM4EU-mom” randomized control trial (10/2020 – 12/2021, Horizon2020 Programme Contract No.733032 ) with the involvement of 130 women of 18-45 years in a healthy singleton pregnancy, willing to eat fish. 15 trained obstetricians nation-wide recruit women under their care and take their hair sample during routine pregnancy appointments. RESULTS:Within one month, 78 pregnant women, corresponding to 60% of the recruitment target, were successfully recruited and provided hair samples. Virtually all women invited to join the study, consent to participation. Some women provide their informed consent at the time of invitation, while others review the information for participants at home and return the completed certificate of informed consent at the next scheduled meeting. Based on current data, it is predicted that the recruitment target will be reached within two months total. CONCLUSIONS:Recruitment of pregnant women and sampling by obstetricians is successful because it builds on the trust that the pregnant women feel towards their health care provider. It also overcomes obstacles due to the COVID-19 pandemic, creates educational opportunities for the doctors and facilitates the communication of personal results to the participants via their health care provider. KEYWORDS: Community-engaged research, Policy, Chemical exposures, Heavy metals, Exposure assessment, Pregnancy outcomes

Maternal serum concentrations of bisphenol A and propyl paraben in early pregnancy are associated with male infant genital development.

Are maternal serum phthalate metabolite, phenol and paraben concentrations measured at 10-17weeks of gestation associated with male infant genital developmental outcomes, specifically cryptorchidism, anogenital distance (AGD), penile length and testicular descent distance, at birth and postnatally? Maternal serum bisphenol A (BPA) concentration at 10-17weeks of gestation was positively associated with congenital or postnatally acquired cryptorchidism, and n-propyl paraben (n-PrP) concentration was associated with shorter AGD from birth to 24months of age. Male reproductive disorders are increasing in prevalence, which may reflect environmental influences on foetal testicular development. Animal studies have implicated phthalates, BPA and parabens, to which humans are ubiquitously exposed. However, epidemiological studies have generated conflicting results and have often been limited by small sample size and/or measurement of chemical exposures outside the most relevant developmental window. Case-control study of cryptorchidism nested within a prospective cohort study (Cambridge Baby Growth Study), with recruitment of pregnant women at 10-17 postmenstrual weeks of gestation from a single UK maternity unit between 2001 and 2009 and 24months of infant follow-up. Of 2229 recruited women, 1640 continued with the infancy study after delivery, of whom 330 mothers of 334 male infants (30 with congenital cryptorchidism, 25 with postnatally acquired cryptorchidism and 279 unmatched controls) were included in the present analysis. Maternal blood was collected at enrolment, and serum levels of 16 phthalate metabolites, 9 phenols (including BPA) and 6 parabens were measured using liquid chromatography/tandem mass spectrometry. Logistic regression was used to model the association of cryptorchidism with serum chemical concentrations, adjusting for putative confounders. Additionally, offspring AGD, penile length and testicular descent distance were assessed at 0, 3, 12, 18 and 24months of age, and age-specific Z scores were calculated. Associations between serum chemical levels and these outcomes were tested using linear mixed models. Maternal serum BPA concentration was associated with offspring all-type cryptorchidism both when considered as a continuous exposure (adjusted odds ratio per log10 μg/l: 2.90, 95% CI 1.31-6.43, P = 0.009) and as quartiles (phet = 0.002). Detection of n-PrP in maternal serum was associated with shorter AGD (by 0.242 standard deviations, 95% CI 0.051-0.433, P = 0.01) from birth to 24months of age; this reduction was independent of body size and other putative confounders. We did not find any consistent associations with offspring outcomes for the other phenols, parabens, and phthalate metabolites measured. We cannot discount confounding by other demographic factors or endocrine-disrupting chemicals. There may have been misclassification of chemical exposure due to use of single serum measurements. The cohort was not fully representative of pregnant women in the UK, particularly in terms of smoking prevalence and maternal ethnicity. Our observational findings support experimental evidence that intrauterine exposure to BPA and n-PrP during early gestation may adversely affect male reproductive development. More evidence is required before specific public health recommendations can be made. This work was supported by a European Union Framework V programme, the World Cancer Research Fund International, the Medical Research Council (UK), Newlife the Charity for Disabled Children, the Mothercare Group Foundation, Mead Johnson Nutrition and the National Institute for Health Research Cambridge Comprehensive Biomedical Research Centre. Visiting Fellowship (J.M.): Regional Programme 'Jiménez de la Espada' for Research Mobility, Cooperation and Internationalization, Seneca Foundation-Science and Technology Agency for the Region of Murcia (No. 20136/EE/17). K.O. is supported by the Medical Research Council (UK) (Unit Programme number: MC_UU_12015/2). The authors declare no conflict of interest.

Prevalence and severity of low back- and pelvic girdle pain in pregnant Nepalese women

BackgroundLow back pain (LBP) and pelvic girdle pain (PGP) are commonly reported during pregnancy and are known to affect pregnant women’s well-being. Still, these conditions are often considered to be a normal part of pregnancy. This study assesses the prevalence and severity of LBP and/or PGP among pregnant Nepalese women, as well as exploring factors associated with LBP and PGP.MethodsA cross-sectional study with successive recruitment of pregnant women was conducted at two district hospitals in Nepal from May 2016 to May 2017. The data was collected using self-reported questionnaires. Univariate and multivariate logistic regression were used to assess the associations between independent variables and LBP and/or PGP.ResultsA total of 1284 pregnant women were included in the study. The reported prevalence of pregnancy-related LBP and/or PGP was 34%. Pain intensity was high with a mean score (standard deviation) of 6 (2). The median (25th-75th percentiles) disability scores according to the total Pelvic Girdle Questionnaire and Oswestry Disability Index were 20 (10–32) and 30 (21–38), respectively. Even though only 52% of the women believed that the pain would disappear after delivery, concern about LBP and/or PGP was reported to be low (median 2 (0–4) (Numeric Rating Scale 0–10)). In the final model for women with LBP and/or PGP the adjusted odds ratios were for body mass index (20–24, 25–30, > 30) 0.7 (95% confidence interval (CI), 0.44–1.21), 1.1 (95% CI, 0.66–1.83), and 1.5 (95% CI, 0.78–2.94) respectively, for pelvic organ prolapse symptoms 6.6 (95% CI, 4.93–8.95) and for women with educated husbands (primary or secondary, higher secondary or above) 1.1 (95% CI, 0.53–2.16) and 1.7 (95% CI, 0.84–3.47), respectively.ConclusionsPregnant Nepalese women commonly report LBP and/or PGP. The women experienced low disability despite severe pain intensity and poor beliefs in recovery after delivery.

A qualitative study on stakeholders\u2019 views on the participation of pregnant women in the APOSTEL VI study: a low-risk obstetrical RCT

BackgroundBioethicists argue that inclusion of pregnant women in clinical research should be more routine to increase the evidence-base for pregnant women and foetuses. Yet, it is unknown whether pregnant women and others directly involved are willing to be routinely included. Therefore, we first need to establish what these stakeholders think about research participation in regular pregnancy-related research. However, studies on their views are scarce. In our study, we piggy-backed on a relatively conventional RCT, the APOSTEL VI study, to identify the views of stakeholders on inclusion of pregnant women in this study.MethodsWe conducted a prospective qualitative study using 35 in-depth semi-structured interviews and one focus group. We interviewed pregnant women (n = 14) recruited for the APOSTEL VI study, in addition to healthcare professionals (n = 14), Research Ethics Committee members (RECs) (n = 5) and regulators (n = 7) involved in clinical research in pregnant women.ResultsThree themes characterise stakeholders’ views on inclusion of pregnant women in the APOSTEL VI study. Additionally, one theme characterises stakeholders’ interest in inclusion of pregnant women in clinical research in general. First, pregnant women participate in the APOSTEL VI study for potential individual benefit and secondarily for altruistic motives, contrary to hypothetical studies. Second, a gatekeeping tendency hampers recruitment of pregnant women who might be eligible and willing, and questions about pregnant women’s decisional capacities surface. Third, healthcare professionals sometimes use the counselling conversation to steer pregnant women in a direction. Fourth, all stakeholders are hesitant about inclusion of pregnant women in clinical research in general due to a protective sentiment.ConclusionsPregnant women are willing to participate in the APOSTEL VI study for potential individual benefit and altruistic motives. However, an underlying protective sentiment, resulting in gatekeeping and directive counselling, sometimes hampers recruitment in the APOSTEL VI study as well as in clinical research in general. While bioethicists claim that inclusion of pregnant women should be customary, our study indicates that healthcare professionals, regulators, RECs and pregnant women themselves are not necessarily interested in inclusion. Advancing the situation and increasing the evidence-base for pregnant women and foetuses may require additional measures such as investing in the recruitment and feasibility of RCTs and stimulating pregnant women’s decisional capacities.

Interm Report of the Highlow Study: A Randomized Controlled Trial Comparing Two Doses of Low Molecular Weight Heparin for the Prevention of Pregnancy-Associated Recurrent Venous Thromboembolism

INTRODUCTIONWomen with a history of venous thromboembolism (VTE) have a 2% to 10% absolute risk of developing pregnancy-associated recurrent VTE. Based on these figures, current guidelines recommend postpartum thromboprophylaxis in all pregnant women with a history of VTE. Women with a moderate or high risk of recurrent VTE (i.e. women with a history of VTE that is either unprovoked or associated with a hormonal or minor risk factor), should also receive thromboprophylaxis antepartum.The optimal dose of low-molecular-weight heparin (LMWH) for thromboprophylaxis in pregnant women at moderate or high risk of recurrent VTE is currently unknown, as only two very small prospective trials, both with methodological limitations, have evaluated pharmacological prevention of recurrent VTE in this population. Therefore, the major international guidelines suggest the use of either a prophylactic or intermediate (half-therapeutic) dose of LMWH in this setting, without a preference of one dose over the other. The Highlow study is an investigator-initiated, multicenter, international, open-label, randomized controlled trial (RCT) that compares the efficacy and safety of a fixed dose of LMWH versus an intermediate dose of LMWH for the prevention of pregnancy-associated recurrent VTE (NCT 01828697; www.highlowstudy.org). The rationale and design features of the Highlow study were recently published [Bleker SM, Thromb Res, 2016]. Here, we present an interim report.METHODSIn April 2013, we enrolled the first patient in the Highlow study. For the current report, we analyzed the enrolment rates and baseline characteristics of patients in the Highlow study between 1 April 2013 and 28 June 2016. Twelve centers recorded eligible women that did not give informed consent. Using the enrolment data from these centers, we analyzed the percentage of women giving informed consent, and reasons for not giving consent. All characteristics were summarized using descriptive statistics.RESULTSA total of 222 pregnant patients with a history of VTE that fitted the in- and exclusion criteria of the Highlow study were enrolled in 43 centers in 5 countries (Figure 1). The inclusion rate has been growing exponentially over time (Figure 2). In 12 centers that recorded eligible women not giving consent, 101 of 149 identified patients gave informed consent (68%). Patients who declined participation either did not give a specific reason (N=22; 46%), preferred a low dose of LMWH (N=20; 42%), preferred an intermediate dose (N=2; 4%), preferred a therapeutic dose (N=2; 4%), refused antepartum prophylaxis (N=1; 2%) or had been advised by another physician not to participate (N=1; 2%).On 28 June 2016, baseline data in the CRF had been completed for 181 patients. Six patients participated twice. The mean age was 33 years ± 5.1, with a mean body mass index of 26.7 ± 5.9. The majority had a history of lower limb deep vein thrombosis (N=102; 56%) or pulmonary embolism (N=72, 40%). Of all previous VTE, the majority was hormone-related (N=97; 54%) or related to pregnancy (N=58; 32%). In total, 34 (19%) of prior VTE were unprovoked, and in only 19 cases (11%) a minor risk factor had been present. Thrombophilia screening had been performed previously in 101 patients (56%) and more than half of them (59 patients, 58%) had positive tests, especially for heterozygous factor V Leiden (N=39; 64%) and the heterozygous prothrombin 20210A mutation (N=13; 22%).CONCLUSIONSThis report represents the largest number of pregnant women with a history of VTE participating in a RCT to date, and the future results are very likely to impact current clinical practice and consensus guidelines. Reassuringly, our enrolment rate shows that recruitment of pregnant women with a history of VTE is feasible. With the current enrolment rate we expect to include the last patient, reaching the event-driven sample size of approximately a 1000 patients, by the end of 2019. Hence, the outcome results can be expected in 2020.SPONSORSHIP AND FINANCIAL SUPPORTAn unrestricted grant is provided by Aspen Pharma to the Academic Medical Center in Amsterdam (the Netherlands), who is the sponsor of the Highlow study. In France, where CHU de Saint Etienne is the sponsor, a grant was acquired from the French Ministry of Health (PHRC national 2014). [Display omitted] [Display omitted] DisclosuresBuchmüller:French Ministry of Health: Research Funding. Chauleur:Sanofi: Honoraria; French Ministry of Health: Research Funding. Ní Áinle:Actelion UK: Research Funding. Verhamme:Boehringer Ingelheim: Honoraria, Research Funding; Bayer-Healthcare: Honoraria, Research Funding; Pfizer: Honoraria; Sanofi-Aventis: Honoraria, Research Funding; LeoPharma: Research Funding; Daiichi-Sankyo: Honoraria. Décousus:French Ministry of Health: Research Funding.

Prenatal paracetamol exposure is associated with shorter anogenital distance in male infants

STUDY QUESTIONWhat is the relationship between maternal paracetamol intake during the masculinisation programming window (MPW, 8–14 weeks of gestation) and male infant anogenital distance (AGD), a biomarker for androgen action during the MPW?SUMMARY ANSWERIntrauterine paracetamol exposure during 8–14 weeks of gestation is associated with shorter AGD from birth to 24 months of age.WHAT IS ALREADY KNOWNThe increasing prevalence of male reproductive disorders may reflect environmental influences on foetal testicular development during the MPW. Animal and human xenograft studies have demonstrated that paracetamol reduces foetal testicular testosterone production, consistent with reported epidemiological associations between prenatal paracetamol exposure and cryptorchidism.STUDY DESIGN, SIZE, DURATIONProspective cohort study (Cambridge Baby Growth Study), with recruitment of pregnant women at ~12 post-menstrual weeks of gestation from a single UK maternity unit between 2001 and 2009, and 24 months of infant follow-up. Of 2229 recruited women, 1640 continued with the infancy study after delivery, of whom 676 delivered male infants and completed a medicine consumption questionnaire.PARTICIPANTS/MATERIALS, SETTING, METHODMothers self-reported medicine consumption during pregnancy by a questionnaire administered during the perinatal period. Infant AGD (measured from 2006 onwards), penile length and testicular descent were assessed at 0, 3, 12, 18 and 24 months of age, and age-specific Z scores were calculated. Associations between paracetamol intake during three gestational periods (<8 weeks, 8–14 weeks and >14 weeks) and these outcomes were tested by linear mixed models. Two hundred and twenty-five (33%) of six hundred and eighty-one male infants were exposed to paracetamol during pregnancy, of whom sixty-eight were reported to be exposed during 8–14 weeks. AGD measurements were available for 434 male infants.MAIN RESULTS AND THE ROLE OF CHANCEParacetamol exposure during 8–14 weeks of gestation, but not any other period, was associated with shorter AGD (by 0.27 SD, 95% CI 0.06–0.48, P = 0.014) from birth to 24 months of age. This reduction was independent of body size. Paracetamol exposure was not related to penile length or testicular descent.LIMITATIONS, REASONS FOR CAUTIONConfounding by other drugs or endocrine-disrupting chemicals cannot be discounted. The cohort was not fully representative of pregnant women in the UK, particularly in terms of maternal ethnicity and smoking prevalence. There is likely to have been misclassification of paracetamol exposure due to recall error.WIDER IMPLICATIONS OF THE FINDINGSOur observational findings support experimental evidence that intrauterine paracetamol exposure during the MPW may adversely affect male reproductive development.STUDY FUNDING/COMPETING INTERESTSThis work was supported by a European Union Framework V programme, the World Cancer Research Fund International, the Medical Research Council (UK), the Newlife Foundation for Disabled Children, the Evelyn Trust, the Mothercare Group Foundation, Mead Johnson Nutrition, and the National Institute for Health Research Cambridge Comprehensive Biomedical Research Centre. The authors declare no conflict of interest.

209-POS

Objectives To verify the behavior of glycosylated hemoglobin (HbA1c) and homeostasis model assessment (HOMA), which assesses insulin resistance from insulin and fasting glucose levels in pregnant women with GDM after an aerobic training on a cycle ergometer. Methods Randomized clinical trial where mothers with GDM are randomly allocated to the intervention group (IG), which is part of a program of regular aerobic exercise with 50-min sessions, three times a week for 10 weeks, or the control group (CG), which makes stretching and relaxation sessions with 50 min once a week for 10 week. The groups are selected from prenatal clinics in the Hospital de Clinicas de Porto Alegre. Results At this moment, six patients completed the proposed trainings, two in the intervention group and four in the control group. We will only describe the data, since the present study is still in progress, under recruitment of pregnant women. The average age of IG is 30.5 ± 9.2 years and in CG 27.5 ± 8.7 years. Four are primiparous and two are pregnant for the fourth time. At baseline, the overall mean HbA1c is 5.2 ± 0.5 and 6.1 ± 2.0 HOMA. After the intervention of 10 weeks, the overall mean HbA1c is 5.5 ± 0.4 and 6.3 ± 4.0 HOMA. The mean gestational age at IG and CG is the same, 38 weeks and 5 days ± 1 day. Weight and height of the newborn IG was 3620.0 ± 714.2 g and 49.5 ± 2.1 cm, respectively, and in controls was 4037.5 ± 180.5 g and 50.8 ± 2.2 cm, respectively. Conclusions After 10 weeks of training we noticed an increase in mean HbA1c and HOMA, compared to baseline, and that the intervention group delivered lighter and smaller babies. Disclosures J.G. Ramos: None. R. Bgeginski: None. M.L. Opperman: None. S. Martins-Costa: None. R. Delevatti: None. R. Schuch: None. L.F. Kruel: None.

Reducing alcohol use during pregnancy via health counseling by midwives and internet-based computer-tailored feedback: a cluster randomized trial.

BackgroundEffective interventions are needed to reduce neurobehavioral impairments in children due to maternal alcohol use during pregnancy. Currently, health-counseling interventions have shown inconsistent results to reduce prenatal alcohol use. Thus, more research using health counseling is needed to gain more knowledge about the effectiveness of this type of intervention on reducing alcohol use during pregnancy. An alternative and promising strategy is computer tailoring. However, to date, no study has shown the effectiveness of this intervention mode.ObjectiveThe aim was to test the effectiveness of health counseling and computer tailoring on stopping and reducing maternal alcohol use during pregnancy in a Dutch sample of pregnant women using alcohol.MethodsA total of 60 Dutch midwifery practices, randomly assigned to 1 of 3 conditions, recruited 135 health counseling, 116 computer tailoring, and 142 usual care respondents from February to September 2011. Health-counseling respondents received counseling from their midwife according to a health-counseling protocol, which consisted of 7 steps addressed in 3 feedback sessions. Computer-tailoring respondents received usual care from their midwife and 3 computer-tailored feedback letters via the Internet. Usual care respondents received routine alcohol care from their midwife. After 3 and 6 months, we assessed the effect of the interventions on alcohol use.ResultsMultilevel multiple logistic regression analyses showed that computer-tailoring respondents stopped using alcohol more often compared to usual care respondents 6 months after baseline (53/68, 78% vs 51/93, 55%; P=.04). Multilevel multiple linear regression analyses showed that computer-tailoring respondents (mean 0.35, SD 0.31 units per week) with average (P=.007) or lower (P<.001) alcohol use before pregnancy or with average (P=.03) or lower (P=.002) social support more strongly reduced their alcohol use 6 months after baseline compared to usual care respondents (mean 0.48, SD 0.54 units per week). Six months after baseline, 72% (62/86) of the health-counseling respondents had stopped using alcohol. This 17% difference with the usual care group was not significant.ConclusionsThis is the first study showing that computer tailoring can be effective to reduce alcohol use during pregnancy; health counseling did not effectively reduce alcohol use. Future researchers developing a health-counseling intervention to reduce alcohol use during pregnancy are recommended to invest more in recruitment of pregnant women and implementation by health care providers. Because pregnant women are reluctant to disclose their alcohol use to health professionals and computer tailoring preserves a person’s anonymity, this effective computer-tailoring intervention is recommended as an attractive intervention for pregnant women using alcohol.Trial RegistrationDutch Trial Register NTR 2058; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2058 (Archived by WebCite at http://www.webcitation.org/6NpT1oHol)

Recruitment of pregnant women in research

The aim was to identify factors that could influence recruitment in a prospective longitudinal study involving pregnant women. A total of 269 nulliparous women were enrolled for a prospective longitudinal study, to establish the prevalence of levator ani muscle defects during childbirth. The project was explained verbally and potential participants were given an information leaflet. When eligible and interested, they provided their contact details to enquire if they were willing to participate. Out of the 1,473 women approached, 269 (18.3%) agreed to participate and 1,043 (70.8%) declined; 420 women (40.3%) did not provide a reason for non-participation (see text for further details). Most often mentioned reasons were ‘being too busy’, ‘other pregnancy problems’, ‘no additional (internal) examination’, ‘moving (abroad)’ and ‘husband’. Women from different ethnicities and age groups gave a wide variety of reasons for non-participation. This information can now be used by researchers recruiting women for comparable studies, to enhance recruitment and participation of eligible patients.

The development of a standard training toolkit for research studies that recruit pregnant women in labour

Recruitment of pregnant women in labour to clinical trials poses particular challenges. Interpretation of regulation lacks consistency or clarity and variation occurs as to the training required by clinicians to safely contribute to the conduct of intrapartum studies. The Royal College of Obstetricians and Gynaecologists Intrapartum Clinical Study Group initiated the development of a pragmatic, proportionate and standardised toolkit for training clinical staff that complies with both regulatory and clinician requirements and has been peer-reviewed. This approach may be useful to researchers in acute care settings that necessitate the integration of research, routine clinical practice and compliance with regulation.