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

This study has been completed.
Sponsor:
Information provided by:
Erzincan Military Hospital
ClinicalTrials.gov Identifier:
NCT01099280
First received: April 5, 2010
Last updated: April 8, 2011
Last verified: March 2010
  Purpose

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.


Condition Intervention Phase
Labor
Induction
PROM (Pregnancy)
Drug: SYNPITAN FORT 5 IU
Drug: Propess,SYNPITAN FORT
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Erzincan Military Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • labor induction-to-delivery interval [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 225
Study Start Date: November 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: oxytocin group
2 milliunits/min and doubled every 30 minutes to a maximum of 32 milliunits/min or until four contractions in 10 minutes was achieved
Drug: SYNPITAN FORT 5 IU
A standard intravenous oxytocin was administered 6 hours after the insertion of the vaginal pessary. An initial dose of 2 mU/min was increased at 30 minute intervals by 2 mU/min to a maximum dose 32 mU/min or until four contractions in 10 minutes was achieved. Once started, oxytocin infusion was continued to delivery unless otherwise indicated. The pessary has been removed if it was still present 12 h after placement; or if worrisome FHR pattern persisted
Experimental: dinoprostone and oxytocin
a single dose sustained-released dinoprostone into the posterior vaginal fornix. A standard intravenous oxytocin was administered 6 hours after the insertion of the vaginal pessary. An initial dose of 2 mU/min was increased at 30 minute intervals by 2 mU/min to a maximum dose 32 mU/min or until four contractions in 10 minutes was achieved
Drug: Propess,SYNPITAN FORT
a single dose sustained-released dinoprostone into the posterior vaginal fornix. A standard intravenous oxytocin was administered 6 hours after the insertion of the vaginal pessary. An initial dose of 2 mU/min was increased at 30 minute intervals by 2 mU/min to a maximum dose 32 mU/min or until four contractions in 10 minutes was achieved

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women with a live singleton fetus at term [37-42 weeks of gestation in cephalic presentation
  • reactive nonstress test (NST)
  • presenting with PROM
  • a Bishop score of 5 or less before the onset of labor
  • an absence of spontaneous contractions

Exclusion Criteria:

  • Women in active labor
  • previous uterine surgery,
  • antepartum hemorrhage,
  • chorioamnionitis,
  • contraindication to prostaglandin use (bronchial asthma, glaucoma), *contraindication to vaginal delivery,
  • multiple pregnancy,
  • non-vertex presentation
  • major fetal anomalies
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01099280

Locations
Turkey
Bakırkoy Women and Children Hospital
İstanbul, Yanimahalle, Turkey, 34142
Sponsors and Collaborators
Erzincan Military Hospital
  More Information

No publications provided

Responsible Party: No sponsor, Bakırkoy Women and Children Hospital
ClinicalTrials.gov Identifier: NCT01099280     History of Changes
Other Study ID Numbers: Gungorduk-08
Study First Received: April 5, 2010
Last Updated: April 8, 2011
Health Authority: United States: Food and Drug Administration
Turkey: Ethics Committee

Keywords provided by Erzincan Military Hospital:
induction of labor in term
premature rupture of membranes
dinoprostone
oxytocin

Additional relevant MeSH terms:
Fetal Membranes, Premature Rupture
Obstetric Labor Complications
Pregnancy Complications
Dinoprostone
Oxytocin
Oxytocics
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014