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Premature Rupture of Membranes With a Bishop Score<6: Comparison of Medical Induction/Expectant Management

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ClinicalTrials.gov Identifier: NCT02825641
Recruitment Status : Recruiting
First Posted : July 7, 2016
Last Update Posted : July 27, 2020
Sponsor:
Information provided by (Responsible Party):
ROY LAUTERBACH MD, Rambam Health Care Campus

Brief Summary:

The study is intended to compare expectant management and on presentation labor induction in women with premature rupture of membranes.

The means of labor induction and cervical ripening are either oxytocin or dinoprostone.

Expectant management in this obstetrical state means waiting 24 hours from the onset of rupture of membranes and then commencing labor induction with either oxytocin or dinoprostone depending on the patient`s obstetrical history and cervical condition.

The investigators` hypothesis is that active management will lead to a higher rate of vaginal deliveries, a shorter interval between the time of rupture of membranes and the time of delivery, a lower rate of cesarean sections and a better obstetric result for the mother and the fetus/newborn.


Condition or disease Intervention/treatment Phase
Medical Induction of Labor Affecting Newborn Drug: Oxytocin Drug: Dinoprostone Not Applicable

Detailed Description:

In the setting of premature rupture of membranes in term pregnancies, it is customary in women who are not in active labor to wait for 24 hours before attempting to induce labor. The means of labor induction used at our medical center are either intravenous oxytocin or per-vaginal dinoprostone, depending on patient`s obstetric history and cervical conditions.

The investigators hypothesize that commencing induction of labor at presentation in these women by either means of induction will lead to higher rates of vaginal delivery, shorter intervals between the time of onset of rupture of membranes and the time of delivery and lower rates of cesarean sections.

The participants in the study, upon signing informed consents, will be randomized to 4 groups-2 groups of expectant management in which labor induction will be commenced after 24 hours with either oxytocin or dinoprostone and 2 groups of active management in which labor induction will be commenced at presentation with either oxytocin or dinoprostone.

The participants will be followed from the time of presentation with rupture of membranes at the delivery room and until the time of delivery.

Further obstetric, clinical and demographic information will be acquired from the patient`s electronic medical file for analysis accuracy and sub-analysis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Premature Rupture of Membranes at Term With an Unfavorable Cervix (Bishop Score<6): Comparison of Oxytocin, Dinoprostone Induction and Expectant Management
Actual Study Start Date : August 1, 2016
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Active Comparator: Expectant Management-Dinoprostone

Women with premature rupture of membranes who are not in active labor and have an unfavorable cervix (Bishop score<6).

Labor induction will be initiated with Dinoprostone after 24 hours of waiting depending on obstetric history and cervical conditions.

Drug: Dinoprostone

Labor induction and cervical ripening by dinoprostone in women with premature rupture of membranes in 2 types of women:

  1. Induction of labor on presentation at the delivery room.
  2. Induction of labor after 24 hours of rupture of membranes.

Active Comparator: Expectant Management-Oxytocin

Women with premature rupture of membranes who are not in active labor and have an unfavorable cervix (Bishop score<6).

Labor induction will be initiated with oxytocin after 24 hours of waiting depending on obstetric history and cervical conditions.

Drug: Oxytocin

Labor induction and cervical ripening by oxytocin in women with premature rupture of membranes in 2 types of women:

  1. Induction of labor on presentation at the delivery room.
  2. Induction of labor after 24 hours of rupture of membranes.
Other Name: Pitocin

Experimental: Active Management-Dinoprostone

Women with premature rupture of membranes who are not in active labor and have an unfavorable cervix (Bishop score<6).

Labor induction will be initiated with Dinoprostone on presentation depending on obstetric history and cervical conditions.

Drug: Dinoprostone

Labor induction and cervical ripening by dinoprostone in women with premature rupture of membranes in 2 types of women:

  1. Induction of labor on presentation at the delivery room.
  2. Induction of labor after 24 hours of rupture of membranes.

Experimental: Active Management-Oxytocin

Women with premature rupture of membranes who are not in active labor and have an unfavorable cervix (Bishop score<6).

Labor induction will be initiated with oxytocin on presentation depending on obstetric history and cervical conditions.

Drug: Oxytocin

Labor induction and cervical ripening by oxytocin in women with premature rupture of membranes in 2 types of women:

  1. Induction of labor on presentation at the delivery room.
  2. Induction of labor after 24 hours of rupture of membranes.
Other Name: Pitocin




Primary Outcome Measures :
  1. The percentage of participants that achieved vaginal delivery [ Time Frame: Up to 7 days from the time of presentation with rupture of membranes ]

Secondary Outcome Measures :
  1. Interval from the time of onset of premature rupture of membranes and the time of delivery (In minutes) [ Time Frame: Up to 7 days from the time of presentation with rupture of membranes ]
  2. The percentage of participants that required caesarian delivery [ Time Frame: Up to 7 days from the time of presentation with rupture of membranes ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Term pregnancies >37 weeks of gestation.
  • Certain rupture of membranes.
  • Bishop score < 6.
  • Singleton pregnancies.
  • Vertex presentation.
  • No obstetric or clinical contraindications for labor induction.
  • Reactive non stress test on presentation.

Exclusion Criteria:

  • Previous cesarean section.
  • Previous uterine surgeries (Myomectomy etc.).
  • Placenta Previa.
  • Multiple gestation pregnancies.
  • Pregnancies with history of fetal reduction or Intrapartum uterine fetal demise.
  • Known fetal defects/Chromosomal abnormalities.
  • Active genital Herpes.
  • HIV carrier.
  • Contractions that are less than 10 minutes apart.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02825641


Contacts
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Contact: Roy Lauterbach, MD 972529432416 r_lauterbach@rambam.health.gov.il

Locations
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Israel
Rambam health care campus Recruiting
Haifa, Israel
Contact: Roy Lauterbach, MD    0529432416    r_lauterbach@rambam.health.gov.il   
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
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Principal Investigator: Amir Weissman, MD Rambam Health Care Campus
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Responsible Party: ROY LAUTERBACH MD, MD, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT02825641    
Other Study ID Numbers: 0213-15-RMB
First Posted: July 7, 2016    Key Record Dates
Last Update Posted: July 27, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Fetal Membranes, Premature Rupture
Rupture
Obstetric Labor Complications
Pregnancy Complications
Wounds and Injuries
Oxytocin
Dinoprostone
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs