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Premature Rupture of Membrane clinical trials

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NCT ID: NCT06273891 Recruiting - Clinical trials for Premature Rupture of Membrane

Erythromycin Versus Azithromycin for Preterm Prelabor Rupture of Membranes

PRACET
Start date: March 8, 2024
Phase: Phase 3
Study type: Interventional

The goal of this study is to help identify the best antibiotic treatment for pregnant people when their water breaks prematurely (a condition abbreviated as PPROM). Current practice is to attempt to maintain the pregnancy until at least 34 weeks gestational age, when the risks of prematurity to the baby are lessened. Research shows that antibiotics help the pregnancy last longer, but there have been limited studies about which combination works best. Currently, both azithromycin and erythromycin are accepted antibiotic treatments, in addition to ampicillin and amoxicillin. Participants diagnosed with PPROM will be randomized to receive ampicillin and amoxicillin plus either azithromycin or erythromycin, in addition to the care they would normally receive. Studying these two drugs will help decide the best care for future patients with PPROM.

NCT ID: NCT05134688 Not yet recruiting - Clinical trials for Premature Rupture of Membrane

Magnesium Sulphate in Premature Rupture of Membranes

Start date: May 30, 2022
Phase: Early Phase 1
Study type: Interventional

To assess the outcome of using magnesium sulphate on fetus and women with preterm premature rupture of membranes

NCT ID: NCT04632017 Recruiting - Sepsis Clinical Trials

Computerized Cardiotocography Monitoring of Fetuses With pPROM

COCA-PROM
Start date: June 15, 2020
Phase:
Study type: Observational

Preterm premature rupture of membranes (PPROM) is associated with neonatal complications leading to a high rate of cerebral palsy, sepsis, and death. Choosing the best time of delivery is crucial to improve fetal outcome. The balance is between a premature delivery exposing the infant to all the risk of prematurity, and keeping the baby in utero, prolonging the exposure to an adverse intrauterine milieu. There are no objective and reproducible tools to help in this decision-making process. Techniques most frequently used for fetal surveillance are biased by high inter- and intra-observer variability. Computerized cardiotocography (cCTG) identifies several objective parameters related to fetal heart rate (FHR) to determine fetal well-being. cCTG has been successfully used in fetuses with intrauterine growth restriction, but it has never been used in prospective studies to assess its role in the management of fetuses with PPROM. The investigators designed a case control study to highlight cCTG differences in PPROM pregnancies versus physiological pregnancies, to establish the effectiveness in predicting adverse outcome, and to develop a score to predict neonatal outcome.

NCT ID: NCT04558996 Recruiting - Covid19 Clinical Trials

Spanish Registry of Pregnant Women With COVID-19

OBS COVID
Start date: March 1, 2020
Phase:
Study type: Observational [Patient Registry]

Study title Spanish Registry of Pregnant Women with COVID-19 Protocol number and version Number 55/20. Version V8. Sponsors This registry is a project promoted by Dr. Oscar Martínez Pérez of the Obstetrics and Gynaecology department of the Puerta de Hierro University Hospital. Principal investigator of the registry National coordinator: Dr. Óscar Martínez Pérez. Obstetrics and Gynaecology Department. Puerta de Hierro University Hospital. Majadahonda. Epidemiologist: Maria Luisa de la Cruz Conti Researchers for each site: 100 sites from 32 Spanish provinces are included (Appendix 1) Funding Neither the hospitals nor the participating investigators will receive any financial compensation for their collaboration. A bank account has been opened at the hospital's Biomedical Research Foundation to receive donations: COV20/00021 - SARS-COV-2 and the COVID-19 disease Call financed by the Carlos III Institute of Health and co-financed with ERDF funds. Abstract Rationale: Knowledge about the impact of the SARS-CoV-2 virus on pregnancy is still scarce and all current recommendations are based on less than 100 cases published in the literature. To identify moderate effects (such as vertical transmission, obstetric morbidity, foetal death, maternal or neonatal death) and to allow accurate risk estimates, larger sample sizes than those currently available are required. Methods: Prospective observational study of pregnant women in whom SARS-CoV-2 infection is suspected at any time during pregnancy with positive test results for SARS-CoV-2, in order to create a registry of baseline characteristics of the pregnant woman, aspects related to the course of pregnancy and delivery, and related to the new-born, with an observation period of up to 14 days after delivery. Subsequently, several phased studies will be conducted to help establish and monitor the set of measures to improve the care of pregnant women. Discussion: The national registry for COVID-19 in pregnancy described here is a tool for sharing and centralizing data related to exposures to SARS-CoV-2 during pregnancy in a structured way. It should speed up the process of prospectively obtaining a large unbiased data set and will collect information at national level.

NCT ID: NCT04478942 Recruiting - Clinical trials for Induction of Labor Affected Fetus / Newborn

PROMMO Trial: Oral Misoprostol vs IV Oxytocin

PROMMO
Start date: October 26, 2020
Phase: Early Phase 1
Study type: Interventional

This is a prospective, randomized trial looking at the ideal method of labor induction for women with prelabor rupture of membranes and an unfavorable cervical Bishop score. The study will compare oral misoprostol and intravenous oxytocin.

NCT ID: NCT04451109 Enrolling by invitation - Clinical trials for Gestational Diabetes

Dilapan-S®: A Multicenter US E-registry

Start date: December 1, 2020
Phase:
Study type: Observational

Objective of this registry is to collect a representative set of real world data on the use of Dilapan-S® for pre-induction cervical ripening in daily clinical practice. Upon completion of the registry, relevant collected data will be analyzed and published.

NCT ID: NCT04237142 Recruiting - Clinical trials for Premature Rupture of Membrane

Preterm Premature Rupture of Fetal Membranes: Cervical Ultrasound and Biological Markers to Diagnose Prematurity (RECHOBIOL)

RECHOBIOL
Start date: March 10, 2020
Phase: N/A
Study type: Interventional

Our main hypothesis is to consider that the detection of biomarkers on admission combined with the length of the cervix would improve the prediction of the latency period in case of preterm premature rupture of membranes (pPROM). The primary purpose of the protocol is to assess the performance of these tests to predict a latency period <48 hours in case of pPROM.

NCT ID: NCT04143685 Recruiting - Clinical trials for Premature Rupture of Membrane

Labor Induction With Misoprostol Versus Oxytocin in Women With Premature Rupture of Membranes

Start date: December 1, 2019
Phase: N/A
Study type: Interventional

This study compares the rate of vaginal delivery after induction of labor with misoprostol versus oxytocin in women with prelabor rupture of membranes. Participants will be randomized to receive either oral misoprotsol every four hours until going into labor, or intravenous oxytocin in increasing dose.

NCT ID: NCT04100252 Completed - Clinical trials for Premature Rupture of Membrane

The Impact of Amniotic Fluid Index (AFI) on Maternal and Perinatal Outcomes in Pregnant Women With Preterm Premature Rupture of Membranes

AFI in PPROM
Start date: September 1, 2018
Phase:
Study type: Observational

Pregnant women who admitted with the complaint of amniotic fluid leakage between the gestational ages of 23+0 and 33+0 and who finally were diagnosed as PPROM were included in the study. Women with multiple gestations, cervical dilatation above 6 cm at the admission, hypertensive diseases, cervical cerclage, fetal anomalies, olgohydramnios, polihydramnios, and those who declined to involve in the study were excluded. In all included women were examined at the admission for amniotic fluid index via trans abdominal ultrasonography. AFI were measured by four quadrant technique, which is sum of the deepest vertical length of pocket of fluid in each quadrant without any umbilical cord. All included patients were assessed in two groups; women with AFI<5 and those with AFI≥5 cm. Included patients were followed in terms of maternal and fetal complications. Maternal complications were chorioamnionitis, placental abruption, placental retention, postpartum endometritis, postpartum hemorrhage; while fetal complications comprised necessity of admission to neonatal intensive care unit, neonatal sepsis, meconium aspiration syndrome, respiratory distress syndrome, intraventricular hemorrhage, umbilical cord pH below 7.10, APGAR score of 5th minute below 5. All complication rates were compared between the groups. In addition, the time period between the diagnosis of PPROM and the time of delivery was defined as latency period and were compared between the groups.

NCT ID: NCT03689062 Not yet recruiting - Clinical trials for Premature Rupture of Membrane

Premature Rupture of Membranes at 34 to 37 Weeks' Gestation

Start date: May 2019
Phase: N/A
Study type: Interventional

Prelabour rupture of membrane is defined as rupture of membranes prior to the onset of labour. Approximately 8% of pregnant women at term experience PROM, but the decision as to how term PROM should be managed clinically remains controversial, and there is wide variation in practice with no clear consensus on what constitutes optimal treatment. Although for the majority of women labour will start spontaneously within 24 hours following term PROM, up to 4%of women will not experience spontaneous onset of labour within seven days.