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Premature Rupture of Membrane clinical trials

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NCT ID: NCT03607929 Recruiting - Pregnancy Clinical Trials

HIDRATA Study: Efficacy of a Hydration Protocol in Nulliparous Women During Labor

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

Aim. To evaluate the efficacy of optimizing hydration during labor in nulliparous women with respect to reducing the duration of dilation and the second stage of labor, lowering the incidence of Cesarean sections and fever, and also with respect to changes in sodium and osmolarity in blood and urine, and 24 hour diuresis. Background. In the international scientific community there is a lack of consensus regarding the most suitable hydration strategies to be used in the attention of nulliparous women during low risk birth. Insufficient hydration during labor is associated with increased maternal and neonatal morbidity. Design. A randomized, controlled clinical trial with allocation concealment and masking during the evaluation of the results. Methods. A study of nulliparous women whose births and newborn are attended in the Obstetric Service of a University Hospital. The women will be randomized to two groups: the "optimal hydration" group, that will be guaranteed 300 ml/h (intravenous crystalloids and water) with a minimum diuresis of 400 ml/24h; and the "variability in hydration" group, comprised of the administration of intravenous and clear liquid volumes, without any established perfusion rate, based on criteria established by the healthcare professional attending the birth, and without established minimum diuresis. Mother outcomes: duration of labor, Cesarean section, fever, dehydration. Newborn outcomes: distress, hypoglycemia, hyponatremia, jaundice, weight loss in 48h, breastfeeding difficulties. Analysis will be per-protocol. Statistical significance will be set at p<0.05 Discussion. The findings obtained in this study will provide new evidence for considering the benefits of providing women with suitable optimized hydration during labor. Diminishing the clinical practice variability related to hydration strategies applied to nulliparous women attended during labor through the use of a decision-making algorithm to administer optimal hydration, would imply improved health and safety for mothers and their newborn together with reduced maternal and neonatal morbidity. Funding granted in 2015 by the Spanish Health Research Fund (PI 15/00897, Ministry of Health). Keywords: hydration; dehydration; adverse events; labor; Cesarean section, fever.

NCT ID: NCT03491826 Completed - Clinical trials for Premature Rupture of Membrane

Fetal and Maternal Outcome in Preterm Premature Rupture of Membranes (PPROM)

Start date: January 2010
Phase:
Study type: Observational

The aim of this study is to compare fetal and maternal outcome in cases of PPROM before 34 weeks versus after 34 weeks.

NCT ID: NCT03251898 Completed - Neonatal Infection Clinical Trials

Correlation Between Premature Rupture of Membranes and Early-onset Neonatal Infections

Start date: August 15, 2017
Phase:
Study type: Observational [Patient Registry]

This study hypothesizes that early-onset neonatal Infections are related to premature rupture of membrane (PROM) and that early intervention can improve the prognosis of newborns. The objective of this study is to analyze the correlation between PROM and early-onset neonatal infections and to assess the prognosis of newborns. A cohort study is designed to implement the study. The subjects of study group are pregnant women who are diagnosed as PROM or chorioamnionitis and whose gestational age is ≥ 24 weeks. The subjects of control group are pregnant women without PROM and chorioamnionitis. Control group and research group are paired at 1: 1 ratio. The main contents of the study include three aspects. (1) The correlation between PROM and chorioamnionitis. (2) The correlation between PROM and early-onset neonatal infections. (3) The pathogenesis of intrauterine infection and neonatal infection.

NCT ID: NCT03172858 Withdrawn - Clinical trials for Premature Rupture of Membrane

Randomized Control Trial of Intracervical Balloon Placement vs Oxytocin in Women With Term PROM and Unripe Cervices

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

This study is designed to determine if an intracervical balloon catheter (IBC) is better than oxytocin for induction of labor in the setting of premature rupture of membranes (PROM) or breaking the bag of water prior to onset of labor. The investigators suspect that an intracervical balloon catheter will shorten the time interval from initiation of induction of labor to delivery.

NCT ID: NCT03106311 Completed - Clinical trials for Premature Rupture of Membrane

The Use of Quantitative Pregnancy Test in Amniotic Fluid as a Diagnostic Tool for Rupture of Fetal Membranes

Start date: April 10, 2017
Phase: N/A
Study type: Interventional

Two groups will be recruited. The first group are pregnant ladies that have unequivocal rupture of fetal membranes that is diagnosed by seeing the amniotic fluid leakage in the vagina. The second group are normal pregnant ladies without rupture of membranes. both groups will be tested by taking vaginal washing fluid. Quantitative and qualitative pregnancy tests will be measured in this fluid.

NCT ID: NCT02819570 Recruiting - Clinical trials for Premature Rupture of Membrane

Comparison of Two Antibiotic Prophylactic Protocols in Preterm Premature Rupture of the Membranes

Start date: November 2015
Phase: Phase 4
Study type: Interventional

The objective of the study is to compare a new antibiotic protocol with the current prophylactic treatment in routine use and to evaluate obstetric and neonatal outcome: preterm labor, chorioamnionitis and early onset sepsis