Labor Clinical Trial - Induction of Labor in Term Premature Rupture of

Status Completed

Clinical Trial Summary

Prelabor rupture of membranes (PROM) is most commonly defined as rupture of membranes before the onset of labor and occurs in 8% of term pregnancies. A prolonged interval from rupture of membranes to delivery is associated with an increase in the incidence of chorioamnionitis and neonatal sepsis. The management of the term patients with PROM, especially those with an unfavorable cervix, remains controversial. Management options to choose from are immediate induction of labor versus delayed induction or expectant management. Several reports have detailed an increase in maternal and neonatal morbidity with expectant management, whereas active management leads to a shorter interval from PROM to delivery, reducing the risk of postnatal infections. In addition, active management is preferred by patients.

The investigators know that, neonatal intensive care admission, variable decelerations, and primary cesarean delivery rates are positively correlated with a longer admission-to-labor-onset interval in women with PROM . So, to reduce the induction to delivery times, concurrent oxytocin infusion with dinoprostone vaginal pessary use for labor induction in women with PROM may be beneficial. Several studies have shown shorter induction-to-delivery interval with concurrent oxytocin infusion with prostaglandin agent at initiation of labor . However, in these studies, there is a a paucity information in PROM labor induction. Only one randomized control trial have compared the efficacy of concurrent dinoprostone and oxytocin and oxytocin alone in women with term PROM . This study indicated that concurrent vaginal dinoprostone and intravenous oxytocin conferred no advantage over intravenous oxytocin alone for the outcomes of interest, including length of labor patient satisfaction or risk for cesarean delivery. Unfortunately, this study was limited by small sample size.

The aims of this randomized study was to compare two protocols (oxytocin vs. sustained-release dinoprostone followed six hours later by oxytocin) for induction of labour in women with PROM at term and an unfavorable cervix.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

Fetal Membranes, Premature Rupture
Induction
Labor
PROM (Pregnancy)

Clinical Trial Details

NCT number	NCT01099280
Study type	Interventional
Source	Erzincan Military Hospital
Contact
Status	Completed
Phase	Phase 3
Start date	November 2009
Completion date	November 2010

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Induction of Labor in Term Premature Rupture of Membranes: A Comparison Between Oxytocin and Dinoprostone Followed Six Hours Later by Oxytocin

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms