NCT01099280

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

Completed Phase 3 Last updated 8 April 2011

What this trial tests

Phase 3 trial testing SYNPITAN FORT 5 IU in Labor in 225 participants. Completed in 1 November 2010.

Timeline

1 November 2009

Primary endpoint
1 November 2010

1 November 2010

Quick facts

Lead sponsor	Erzincan Military Hospital
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Enrollment	225
Start date	1 November 2009
Primary completion	1 November 2010
Estimated completion	1 November 2010
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• SYNPITAN FORT 5 IU — full drug profile →
• Propess,SYNPITAN FORT — full drug profile →

Conditions studied

• Labor — all drugs for Labor →
• Induction — all drugs for Induction →
• PROM (Pregnancy) — all drugs for PROM (Pregnancy) →

Sponsor

Erzincan Military Hospital

Who can join

Adults 18 to 45, female only, with Labor or Induction. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• the number (rate) of women who succeeded in delivering vaginally within 24 h of the initiation of the labor induction protocol
  Time frame: 24 hours

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.