Characteristics, experiences and actions taken by women to address delayed conception: A mixed-methods cross-sectional study protocol.

BACKGROUND: The impact of infertility on mental, emotional, physical and sexual health is grave, particularly in a pronatalist society. Literature is replete with evidence of wide ranging psychosocial consequences of infertility in women, indicating the need for identifying the gaps and designing appropriate context specific interventions to improve access and utilization of services. Data that are accessible, primarily from infertility clinics and women visiting hospitals for infertility treatment; information from community settings is rare. This is a protocol paper for a study to understand women's experiences and actions taken by them to cope with delayed conception. METHODS: Mixed-methods cross-sectional design is used to obtain deep insights into the experiences of delayed conception, coping mechanisms, medical assistance and other help sought. Information is also being obtained on socio-demographic profile, fertility intentions, fertility quality of life, general medical history, obstetric, gynecological and sexual history, substance use and mental health status. A sample of 1530 women will be administered 4 modules of a quantitative survey. Focus group discussions, about four or till saturation point, will be conducted using purposive sampling. The study is recruiting from a population of women who previously participated in the 'Women and Infants Integrated Interventions for Growth Study (WINGS) and failed to conceive during 18 months follow up period. Data collected through questionnaire will be assembled, cleaned, analyzed and reported. The findings will be disseminated through reports with the ethics review committee, government entities, academic and research publications. DISCUSSION: This study will provide insights on the experiences and coping strategies of women with delayed conception in the study community. Results will assist in designing appropriate interventions to meet the holistic health and psychosocial needs of women with delayed conception and promote sexual and reproductive health within the broader framework of Sustainable Development Goals and Universal health coverage. TRIAL REGISTRATION: Trial registration number: CTRI/2020/03/023955.

Does gentle assisted pushing or giving birth in the upright position reduce the duration of the second stage of labour? A three-arm, open-label, randomised controlled trial in South Africa.

INTRODUCTION: Gentle assisted pushing (GAP) is an innovative method of applying gentle, steady pressure to a woman's uterine fundus during second stage of labour. This randomised trial evaluated GAP in an upright position, compared with upright position alone or routine practice (recumbent posture). METHODS: An open-label, hospital-based, randomised trial was conducted in Eastern Cape, South Africa. Randomisation occurred following at least 15 min in second stage of labour. Participants were randomly assigned (1:1:1) using computer-generated block randomisation of variable size using opaque, sealed, numbered envelopes. Primary analysis was intention to treat. Participants were healthy, nulliparous, consenting women with a singleton pregnancy in cephalic presentation where vaginal birth was anticipated. The primary outcome was mean time from randomisation to birth. RESULTS: 1158 participants were randomly allocated to GAP (n=388), upright position (n=386) and routine practice (n=384), with no loss to follow-up. Baseline characteristics were largely similar. In the experimental arm, GAP was applied a median of two times (IQR 1.0-3.0). Women in upright position alone spent a median of 6 min (IQR 3.0-10.0) upright. Mean duration from randomisation to birth was not different across groups (mean (SD) duration: 24.1 (34.9) min in GAP group, 24.6 (30.5) min in upright group, 25.0 (39.3) min in routine practice group). There were no differences in secondary outcomes, except that at two sites maternal discomfort was greater for both GAP and upright position compared with routine practice; at the other sites there were no differences. CONCLUSION: No benefit was identified from GAP in the second stage; some women found the position uncomfortable. The use of fundal pressure should be limited to further research to determine techniques or settings in which it can safely assist vaginal birth. Women should be encouraged to assume the position they find most comfortable. TRIAL REGISTRATION NUMBER: PACTR201502001034448.

Comparative effectiveness of single and dual rapid diagnostic tests for syphilis and HIV in antenatal care services in Colombia / Comparación de la eficacia de la prueba rápida individual y la prueba rápida dual para el diagnóstico de la sífilis y la infección por el VIH en los servicios de atención prenatal en Colombia

Objective. To assess the effectiveness of a dual rapid test compared to a single rapid test for syphilis and HIV screening. Methods. A cluster-randomized open-label clinical trial was performed in 12 public antenatal care (ANC) centers in the cities of Bogotá and Cali, Colombia. Pregnant women who were over 14 years of age at their first antenatal visit and who had not been previously tested for HIV and syphilis during the current pregnancy were included. Pregnant women were randomized to single HIV and single syphilis rapid diagnostic tests (Arm A) or to dual HIV and syphilis rapid diagnostic tests (Arm B). The four main outcomes measured were: (1) acceptability of the test, (2) uptake in testing, (3) treatment on the same day (that is, timely treatment), and (4) treatment at any time for positive rapid test cases. Bivariate and multivariate analyses were calculated to adjust for the clustering effect and the period. Results. A total of 1 048 patients were analyzed in Arm A, and 1 166 in Arm B. Acceptability of the rapid tests was 99.8% in Arm A and 99.6% in Arm B. The prevalence of positive rapid tests was 2.21% for syphilis and 0.36% for HIV. Timely treatment was provided to 20 of 29 patients (69%) in Arm A and 16 of 20 patients (80%) in Arm B (relative risk (RR), 1.10; 95% confidence interval (CI): (1.00 −1.20). Treatment at any time was given to 24 of 29 patients (83%) in Arm A and to 20 of 20 (100%) in Arm B (RR, 1.11; 95% CI: 1.01−1.22). Conclusions. There were no differences in patient acceptability, testing and timely treatment between dual rapid tests and single rapid tests for HIV and syphilis screening in the ANC centers. Same-day treatment depends also on the interpretation of and confidence in the results by the health providers.

Objetivo. Evaluar la eficacia de la prueba rápida dual en comparación con la prueba rápida individual para la detección sistemática de la sífilis y la infección por el VIH. Métodos. Se realizó un ensayo clínico sin enmascaramiento y aleatorizado por grupos en 12 centros públicos de atención prenatal en las ciudades de Bogotá y Cali (Colombia). Se incluyó a las mujeres embarazadas de 14 o más años de edad que asistían a su primera consulta prenatal y no se habían realizado pruebas en este embarazo. Las embarazadas se dividieron de forma aleatoria para realizarles las pruebas rápidas individuales para el diagnóstico de sífilis y de infección por el VIH (Grupo A) o la prueba rápida dual para el diagnóstico de la sífilis y la infección por el VIH (Grupo B). Se midieron principalmente cuatro resultados: (1) aceptabilidad de la prueba, (2) uso de los servicios de prueba, (3) tratamiento el mismo día (es decir, tratamiento oportuno) y (4) tratamiento en cualquier momento en los casos con resultados positivos en las pruebas rápidas. Se realizaron análisis bifactoriales y multifactoriales para hacer los ajustes pertinentes por el efecto de la división en grupos y el período. Resultados. Se estudió a 1 048 pacientes en el Grupo A y a 1 166 en el Grupo B. La aceptabilidad de las pruebas rápidas fue de 99,8% en el Grupo A y 99,6% en el Grupo B. La prevalencia de resultados positivos en las pruebas rápidas fue de 2,21% para la sífilis y 0,36% para la infección por el VIH. Se administró tratamiento oportuno a 20 de 29 pacientes (69%) del Grupo A y a 16 de 20 pacientes (80%) del Grupo B (riesgo relativo, 1,10; intervalo de confianza de 95% (IC): 1,00-1,20). Se administró tratamiento en cualquier momento a 24 de 29 pacientes (83%) del Grupo A y a 20 de 20 (100%) del Grupo B (riesgo relativo, 1,11; IC de 95%: 1,01-1,22). Conclusiones. No hubo diferencias en cuanto a la aceptabilidad por parte de los pacientes, y el uso de los servicios de cribaje y el tratamiento oportuno entre las pruebas rápidas duales y las pruebas rápidas individuales para la detección sistemática de la sífilis y la infección por el VIH en los centros de atención prenatal. El tratamiento el mismo día depende también de la interpretación y la confianza en los resultados del trabajador de salud.

Comparative effectiveness of single and dual rapid diagnostic tests for syphilis and HIV in antenatal care services in Colombia / Comparación de la eficacia de la prueba rápida individual y la prueba rápida dual para el diagnóstico de la sífilis y la infección por el VIH en los servicios de atención prenatal en Colombia

ABSTRACT Objective To assess the effectiveness of a dual rapid test compared to a single rapid test for syphilis and HIV screening. Methods A cluster-randomized open-label clinical trial was performed in 12 public antenatal care (ANC) centers in the cities of Bogotá and Cali, Colombia. Pregnant women who were over 14 years of age at their first antenatal visit and who had not been previously tested for HIV and syphilis during the current pregnancy were included. Pregnant women were randomized to single HIV and single syphilis rapid diagnostic tests (Arm A) or to dual HIV and syphilis rapid diagnostic tests (Arm B). The four main outcomes measured were: (1) acceptability of the test, (2) uptake in testing, (3) treatment on the same day (that is, timely treatment), and (4) treatment at any time for positive rapid test cases. Bivariate and multivariate analyses were calculated to adjust for the clustering effect and the period. Results A total of 1 048 patients were analyzed in Arm A, and 1 166 in Arm B. Acceptability of the rapid tests was 99.8% in Arm A and 99.6% in Arm B. The prevalence of positive rapid tests was 2.21% for syphilis and 0.36% for HIV. Timely treatment was provided to 20 of 29 patients (69%) in Arm A and 16 of 20 patients (80%) in Arm B (relative risk (RR), 1.10; 95% confidence interval (CI): (1.00 −1.20). Treatment at any time was given to 24 of 29 patients (83%) in Arm A and to 20 of 20 (100%) in Arm B (RR, 1.11; 95% CI: 1.01−1.22). Conclusions There were no differences in patient acceptability, testing and timely treatment between dual rapid tests and single rapid tests for HIV and syphilis screening in the ANC centers. Same-day treatment depends also on the interpretation of and confidence in the results by the health providers.

RESUMEN Objetivo Evaluar la eficacia de la prueba rápida dual en comparación con la prueba rápida individual para la detección sistemática de la sífilis y la infección por el VIH. Métodos Se realizó un ensayo clínico sin enmascaramiento y aleatorizado por grupos en 12 centros públicos de atención prenatal en las ciudades de Bogotá y Cali (Colombia). Se incluyó a las mujeres embarazadas de 14 o más años de edad que asistían a su primera consulta prenatal y no se habían realizado pruebas en este embarazo. Las embarazadas se dividieron de forma aleatoria para realizarles las pruebas rápidas individuales para el diagnóstico de sífilis y de infección por el VIH (Grupo A) o la prueba rápida dual para el diagnóstico de la sífilis y la infección por el VIH (Grupo B). Se midieron principalmente cuatro resultados: (1) aceptabilidad de la prueba, (2) uso de los servicios de prueba, (3) tratamiento el mismo día (es decir, tratamiento oportuno) y (4) tratamiento en cualquier momento en los casos con resultados positivos en las pruebas rápidas. Se realizaron análisis bifactoriales y multifactoriales para hacer los ajustes pertinentes por el efecto de la división en grupos y el período. Resultados Se estudió a 1 048 pacientes en el Grupo A y a 1 166 en el Grupo B. La aceptabilidad de las pruebas rápidas fue de 99,8% en el Grupo A y 99,6% en el Grupo B. La prevalencia de resultados positivos en las pruebas rápidas fue de 2,21% para la sífilis y 0,36% para la infección por el VIH. Se administró tratamiento oportuno a 20 de 29 pacientes (69%) del Grupo A y a 16 de 20 pacientes (80%) del Grupo B (riesgo relativo, 1,10; intervalo de confianza de 95% (IC): 1,00-1,20). Se administró tratamiento en cualquier momento a 24 de 29 pacientes (83%) del Grupo A y a 20 de 20 (100%) del Grupo B (riesgo relativo, 1,11; IC de 95%: 1,01-1,22). Conclusiones No hubo diferencias en cuanto a la aceptabilidad por parte de los pacientes, y el uso de los servicios de cribaje y el tratamiento oportuno entre las pruebas rápidas duales y las pruebas rápidas individuales para la detección sistemática de la sífilis y la infección por el VIH en los centros de atención prenatal. El tratamiento el mismo día depende también de la interpretación y la confianza en los resultados del trabajador de salud.

Comparative effectiveness of single and dual rapid diagnostic tests for syphilis and HIV in antenatal care services in Colombia.

OBJECTIVE: To assess the effectiveness of a dual rapid test compared to a single rapid test for syphilis and HIV screening. METHODS: A cluster-randomized open-label clinical trial was performed in 12 public antenatal care (ANC) centers in the cities of Bogotá and Cali, Colombia. Pregnant women who were over 14 years of age at their first antenatal visit and who had not been previously tested for HIV and syphilis during the current pregnancy were included. Pregnant women were randomized to single HIV and single syphilis rapid diagnostic tests (Arm A) or to dual HIV and syphilis rapid diagnostic tests (Arm B). The four main outcomes measured were: (1) acceptability of the test, (2) uptake in testing, (3) treatment on the same day (that is, timely treatment), and (4) treatment at any time for positive rapid test cases. Bivariate and multivariate analyses were calculated to adjust for the clustering effect and the period. RESULTS: A total of 1 048 patients were analyzed in Arm A, and 1 166 in Arm B. Acceptability of the rapid tests was 99.8% in Arm A and 99.6% in Arm B. The prevalence of positive rapid tests was 2.21% for syphilis and 0.36% for HIV. Timely treatment was provided to 20 of 29 patients (69%) in Arm A and 16 of 20 patients (80%) in Arm B (relative risk (RR), 1.10; 95% confidence interval (CI): (1.00 -1.20). Treatment at any time was given to 24 of 29 patients (83%) in Arm A and to 20 of 20 (100%) in Arm B (RR, 1.11; 95% CI: 1.01-1.22). CONCLUSIONS: There were no differences in patient acceptability, testing and timely treatment between dual rapid tests and single rapid tests for HIV and syphilis screening in the ANC centers. Same-day treatment depends also on the interpretation of and confidence in the results by the health providers.

Antenatal care packages with reduced visits and perinatal mortality: a secondary analysis of the WHO Antenatal Care Trial.

BACKGROUND: In 2001, the WHO Antenatal Care Trial (WHOACT) concluded that an antenatal care package of evidence-based screening, therapeutic interventions and education across four antenatal visits for low-risk women was not inferior to standard antenatal care and may reduce cost. However, an updated Cochrane review in 2010 identified an increased risk of perinatal mortality of borderline statistical significance in three cluster-randomized trials (including the WHOACT) in developing countries. We conducted a secondary analysis of the WHOACT data to determine the relationship between the reduced visits, goal-oriented antenatal care package and perinatal mortality. METHODS: Exploratory analyses were conducted to assess the effect of baseline risk and timing of perinatal death. Women were stratified by baseline risk to assess differences between intervention and control groups. We used linear modeling and Poisson regression to determine the relative risk of fetal death, neonatal death and perinatal mortality by gestational age. RESULTS: 12,568 women attended the 27 intervention clinics and 11,958 women attended the 26 control clinics. 6,160 women were high risk and 18,365 women were low risk. There were 161 fetal deaths (1.4%) in the intervention group compared to 119 fetal deaths in the control group (1.1%) with an increased overall adjusted relative risk of fetal death (Adjusted RR 1.27; 95% CI 1.03, 1.58). This was attributable to an increased relative risk of fetal death between 32 and 36 weeks of gestation (Adjusted RR 2.24; 95% CI 1.42, 3.53) which was statistically significant for high and low risk groups. CONCLUSION: It is plausible the increased risk of fetal death between 32 and 36 weeks gestation could be due to reduced number of visits, however heterogeneity in study populations or differences in quality of care and timing of visits could also be playing a role. Monitoring maternal, fetal and neonatal outcomes when implementing antenatal care protocols is essential. Implementing reduced visit antenatal care packages demands careful monitoring of maternal and perinatal outcomes, especially fetal death.

A multicenter randomized clinical trial of one-rod etonogestrel and two-rod levonorgestrel contraceptive implants with nonrandomized copper-IUD controls: methodology and insertion data.

BACKGROUND: Comparative data on etonogestrel and two-rod levonorgestrel contraceptive implants are lacking. STUDY DESIGN: A multicenter, open, parallel-group trial with random allocation of implants was performed. For every second implant user, an age-matched woman choosing an intrauterine device (IUD) (TCu380A) was admitted. Methods and data on implant/IUD insertion and 6-week follow-up are reported. RESULTS: A total of 2008 women were randomized to an implant, and 974 women were enrolled in the IUD group. Results from 997 etonogestrel implant users, 997 levonorgestrel implant users and 971 IUD users were analyzed. In the etonogestrel and levonorgestrel groups, respectively, mean insertion durations were 51 (SD 50.2) s and 88 (SD 60.8) s; complication rates at insertion were 0.8% and 0.2%; and at follow-up, 27.2% and 26.7% of women, respectively, had signs or symptoms at the insertion site. At follow-up within 6 weeks after insertion, all implants were in situ, while 2.1% of IUDs were expelled. CONCLUSION: Performance of etonogestrel and levonorgestrel implants at insertion and within the first 6 weeks is similar. Short-term (6 weeks) continuation rates appear higher for implants than TCu380A.

Birthweight and perinatal mortality among singletons and twins in north-eastern Tanzania.

BACKGROUND: Low birthweights as well as high perinatal mortality rates are common in most African populations. Little is known, however, about how low birthweight corresponds with higher mortality rates within African populations. Twins are known to have lower birthweights and higher perinatal mortality rates than singletons. If lower birthweights represent higher perinatal risk per se, small twins within a population with generally lower birthweights should have critically increased risks. METHODS: In total, 15,255 births in a Tanzanian hospital during 1999-2006 were analysed to determine birthweight distribution and examine perinatal mortality rates (including stillbirths and neonatal deaths within 24 hours) by birthweight in twins and singletons. Referral births from outside the district where the hospital was situated were excluded from analysis. RESULTS: The mean birthweight for births within an estimated normal distribution was 3,172 g, with a standard deviation of 462 g. The overall perinatal mortality rate was 43.9 per 1,000 births (95% confidence interval: 40.7-47.2). Perinatal mortality rates among twins and singletons were 91.0 and 41.1 per 1000 babies respectively, corresponding to a relative risk of 2.2 (95% confidence interval: 1.7-2.8). The birthweight distribution for twins was shifted to lower birthweights. Twins had a generally lower birthweight and an excess of extremely small births as compared to singletons. The increased mortality rate for twins appeared to be independent of birthweight. CONCLUSIONS: The two-fold increased risk of perinatal death for twins was observed across the whole birthweight distribution, and very small twins appeared to have an excess perinatal risk that was almost similar to that of larger twins.