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Pregnancy Complications clinical trials

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NCT ID: NCT03152058 Recruiting - Clinical trials for Pregnancy Complications

IMPACT Study: IMProve Pregnancy in APS With Certolizumab Therapy

Start date: May 17, 2017
Phase: Phase 2
Study type: Interventional

This treatment trial evaluates the addition of an anti-tumor necrosis factor-alpha drug, certolizumab, to usual treatment (a heparin agent and low-dose aspirin) in pregnant women with antiphospholipid syndrome (APS) and repeatedly positive tests for lupus anticoagulant (LAC) to determine if this regimen will improve pregnancy outcomes. All enrolled patients will receive certolizumab, and pregnancy outcomes will be compared to those of women with APS and repeatedly positive tests for LAC enrolled in a previous study by the investigators.

NCT ID: NCT03151070 Completed - Pre-Eclampsia Clinical Trials

Scaling Up an Integrated Approach to Improve Delivery Care in North Guatemala With Stepped Wedge Design

QVLM
Start date: December 15, 2013
Phase: N/A
Study type: Observational

"¡Que Vivan las Madres!: Venga a tener su parto al CAP" (QVLM) is a guatemalan quasi-experimental study that has been performed from January 2014 to January 2017 by the Epidemiological Research Center in Sexual and Reproductive Health (CIESAR) in Guatemala in coordination with PRONTO International and University of San Francisco, California. This project has been financed by Grands Challenges Canada' "Save Lives at Birth, A Grand Challenge for Development" partnership that includes USAID, Norwegian ministry of foreign affairs, Bill&Melinda Gates foundation, UKaid. This project has applied a stepped wedge design (SWD) over 6 zones or clusters. Each one of the zones contains from 4 to 6 communities, each one with the presence of one second level health facility (known in Spanish as CAP, Centro de Atención Permanente). These health centers are the next level in attention after home, traditional and empirical attention. Communities around the selected health centers are mostly rural and have the worst maternal health indicators in the country. These health centers are expected to have enough equipment and personnel to attend the deliveries that occur in their communities. This study was performed in Huehuetenango and Alta Verapaz districts in north Guatemala. Each one with 3 zones for a total of 6 zones. The study follows a Stepped Wedge Design, in which all 6 zones are eventually intervened, but at different regular periods of time (each period is 4 months long). This project applies a package of 3 simultaneous interventions in each zone with the purpose of increasing institutional deliveries and improving deliveries attention in public health centers. This intervention plan has been implemented in a pilot study reported in (Kestler et. al, 2013).

NCT ID: NCT03112018 Completed - PreTerm Birth Clinical Trials

Strengthening Facility-based Intrapartum/Immediate Newborn Care to Reduce Mortality of Preterm Infants in Migori County, Kenya and Busoga Region, Uganda

PTBi-KE-UG
Start date: October 1, 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether a combination of evidence-based strategies can improve intrapartum and newborn care in facilities to reduce mortality among preterm infants. This will be a cluster randomized implementation science study across 23 facilities in Eastern Uganda and Western Kenya. Selected interventions will be supported in facilities to measure impact during the study period. These interventions are: a) data strengthening and data use activities; b) implementation of a modified WHO Safe Childbirth Checklist with an emphasis on preterm labor and preterm babies; c) simulation-based provider training and mentoring on key existing evidence-based practices to improve newborn outcomes; d) support of Quality Improvement (QI) cycles to identify and resolve facility-specific issues and bottlenecks. A two-stage design will be used where all study facilities will receive some aspects of the intervention initially, namely data strengthening and the modified checklist. Subsequently, the remaining interventions (QI cycles and simulation training of providers) will be rolled out to a randomly selected half of the facilities in the first stage. At a second stage, the remaining half of the facilities will receive the remaining interventions.

NCT ID: NCT03111602 Completed - Clinical trials for Pregnancy Complications

Increase of Prostaglandin E2 in Reversal of Ductal Constriction After Dietary Restriction of Polyphenols

Start date: May 2011
Phase: N/A
Study type: Interventional

INCREASE OF PROSTAGLANDIN E2 IN REVERSAL OF DUCTAL CONSTRICTION AFTER DIETARY RESTRICTION OF POLYPHENOLS. Clinical trial with a healthy group as comparator. The interventional group was made up of third-trimester mothers whose single fetuses had ductal constriction, excluding those exposed to NSAID, and the control group only by third-trimester normal fetuses. The interventional group was submitted to dietary orientation to restrict polyphenol-rich foods and both groups answered a food frequency questionnaire after fetal Doppler-echocardiographic examination and blood draw for PGE2 levels analysis. After two weeks, the women were again submitted to fetal echocardiogram, dietary assessment and blood draw.

NCT ID: NCT03100084 Recruiting - Clinical trials for Pregnancy Complications

PREdelivery Placental Biomarkers- Pregnancy and Delivery Outcome

PREPPeD
Start date: September 15, 2016
Phase:
Study type: Observational

The PREPPeD study proposes that predelivery placenta-derived maternal circulating biomarkers reflect placental health, capacity and ageing, and can help predict onset and complications of delivery both in complicated pregnancies as well as in clinically uncomplicated term/post-term pregnancies.

NCT ID: NCT03099837 Active, not recruiting - Clinical trials for Pregnancy Complications

Tongji Maternal and Child Health Cohort

TMCHC
Start date: January 10, 2013
Phase:
Study type: Observational

This is a population-based study to obtain data for the evaluation of current used recommendations for weight gain during pregnancy released by IOM (2007) and investigate the association between maternal diet and the health outcomes of mother and offspring.

NCT ID: NCT03067298 Completed - Preterm Birth Clinical Trials

Prediction of Preeclampsia and Other Pregnancy Complications Following Combined Iterative Screening

PREDICTION2
Start date: October 2016
Phase:
Study type: Observational

Preterm birth (PTB), preeclampsia (PE), fetal growth restriction (FGR) and intra-uterine fetal death (IUFD) constitutes the main causes of perinatal morbidity and mortality and are called "Great Obstetrical Syndromes". Algorithms to predict those outcomes have been developed by combining maternal characteristics (history, age, BMI, blood pressure), biochemical (sFlt-1, β-hCG, PlGF, AFP) and sonographic (uterine artery Doppler, 3D of placenta, cervical length, nasal bone measurement, nuchal translucency) markers. Another prospective observational study ("PREDICTION study" NCT 02189148) is also ongoing, which aims to validate those algorithms at the first trimester of pregnancy. Recent data suggest that repeating the same measurements later in pregnancy could improve the detection rates, allowing closer monitoring of high-risk patients and potential therapeutics under investigation. The current study (PREDICTION2) is an ancillary study of PREDICTION and aims at validating the use of these markers in a combined iterative manner in the prediction of preeclampsia and other obstetrical outcomes.

NCT ID: NCT03056274 Not yet recruiting - Clinical trials for Pregnancy Complications

Metformin in Intrahepatic Cholestasis of Pregnancy

METRIC
Start date: January 2019
Phase: Phase 2/Phase 3
Study type: Interventional

This is a pilot study aimed at comparing the effect of metformin versus ursodeoxycholic acid in women with intrahepatic cholestasis in pregnancy. The study will be conducted in three NHS hospital sites, over an 18 month period.

NCT ID: NCT03008421 Completed - Clinical trials for Pregnancy Complications

Oral Probiotics to Reduce Vaginal Group B Streptococcal Colonization in Late Pregnancy

Start date: June 1, 2018
Phase: N/A
Study type: Interventional

In the present study, the investigators aim to evaluate the potential of oral probiotics, containing Lactobacillus strains, to eradicate and reduce the vaginal colonization with group B Streptococcus (GBS) during pregnancy. This could help to prevent neonatal morbidity and mortality by reducing the risk for neonatal sepsis, pneumonia, and meningitis, known as early-onset or late-onset GBS infection.

NCT ID: NCT02999347 Completed - Clinical trials for Urinary Incontinence

Pregnancy After Tension-free Vaginal Tape and Other Mid-urethral Sling Procedures

PregnanT
Start date: August 2014
Phase:
Study type: Observational

The purpose of this study is to determine the interactions between pregnancy and urinary stress incontinence in women with a mid-urethral sling (MUS). The specific aims of the 2 sub studies are: Study 1: The main aims of Study 1 are to evaluate any potential impact on urinary stress continence after a pregnancy/delivery following MUS surgery, and to evaluate any potential differences in continence status based on the mode of delivery for these women. Study 2: The aim of Study 2 is to examine how obstetric factors may affect the degree of incontinence in women registered in The Norwegian female incontinence registry prior to surgical treatment. In addition, we want to explore if there are obstetric risk factors predicting failure of a MUS surgery performed after pregnancy/delivery.