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Labor Induction With Misoprostol Versus Oxytocin in Women With Premature Rupture of Membranes

Primary Purpose

Prelabor Rupture of Membranes, Premature Rupture of Membrane

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Misoprostol
Oxytocin
Sponsored by
sammour.rami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prelabor Rupture of Membranes focused on measuring PROM

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Women in their 1st - 4th delivery
  • Term prelabor rupture of membranes (37+0 to 42+0 gestational age)
  • Vertex presentation
  • Singleton pregnancy

Exclusion Criteria:

  • Multiple pregnancy
  • Previous cesarean section
  • Chorioamnionitis on admission
  • >2 symptomatic uterine contractions in 10 minutes
  • Prostaglandins hypersensitivity
  • Contraindication for vaginal delivery

Sites / Locations

  • Bnai Zion Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

misoprostol

oxytocin

Arm Description

misoprostol 50 mcg tablet by mouth every four hours for maximum dosage of six

Oxytocin 10 IU in 1000 mL Standard solution. Starting with 10 mL/hr infusion rate and increasing by 10mL/hr every 20 minutes until achieving 3-5 regular uterine contractions every 10 minutes (as recorded by cardiotocography)

Outcomes

Primary Outcome Measures

Vaginal delivery rate

Secondary Outcome Measures

Operative delivery rate, Cesarean section rate, time interval from induction of labor to delivery
chorioamnionitis rate
intra-amniotic infection during or after delivery representing in possible combination of maternal fever, fetal tachycardia, maternal leukocytosis, Histopathologic evidence of infection or inflammation or both in the placenta, fetal membranes, or the umbilical cord vessels
Uterine tachysystole
Neonatal morbidity
Apgar score, , ,
Neonatal morbidity
Umbilical Cord Blood Gases
Neonatal morbidity
NICU admission
Neonatal morbidity
Antibiotic administration

Full Information

First Posted
December 19, 2018
Last Updated
January 27, 2020
Sponsor
sammour.rami
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1. Study Identification

Unique Protocol Identification Number
NCT04143685
Brief Title
Labor Induction With Misoprostol Versus Oxytocin in Women With Premature Rupture of Membranes
Official Title
Labor Induction With Misoprostol Versus Oxytocin in Women With Premature Rupture of Membranes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
August 1, 2021 (Anticipated)
Study Completion Date
October 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
sammour.rami

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
This study compares the rate of vaginal delivery after induction of labor with misoprostol versus oxytocin in women with prelabor rupture of membranes. Participants will be randomized to receive either oral misoprotsol every four hours until going into labor, or intravenous oxytocin in increasing dose.
Detailed Description
Misoprostol is a synthetic prostaglandin analogue commonly used for labor induction. It causes uterine contractions and ripening of the cervix. Oxytocin sold under the brand name Pitocin among others, is a medication made from the peptide oxytocin and is used to cause contraction of the uterus to start labor. This randomized controlled trial will compare induction of labor in women with term premature rupture of the membranes and unripe cervix using misoprostol versus oxytocin. The primary outcome is the rate of vaginal delivery. Secondary outcomes will include cesarean section rate, time interval from induction of labor to delivery, neonatal morbidity, patient satisfaction and side effects, as well as chorioamnionitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prelabor Rupture of Membranes, Premature Rupture of Membrane
Keywords
PROM

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
misoprostol
Arm Type
Active Comparator
Arm Description
misoprostol 50 mcg tablet by mouth every four hours for maximum dosage of six
Arm Title
oxytocin
Arm Type
Active Comparator
Arm Description
Oxytocin 10 IU in 1000 mL Standard solution. Starting with 10 mL/hr infusion rate and increasing by 10mL/hr every 20 minutes until achieving 3-5 regular uterine contractions every 10 minutes (as recorded by cardiotocography)
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Other Intervention Name(s)
Cytotec, PGE1
Intervention Description
Oral administration of cytotec every 4 hours until a maximum of 6 doses
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
Pitocin
Intervention Description
Intravenous infusion of Pitocin through an IVAC until delivery
Primary Outcome Measure Information:
Title
Vaginal delivery rate
Time Frame
During delivery
Secondary Outcome Measure Information:
Title
Operative delivery rate, Cesarean section rate, time interval from induction of labor to delivery
Time Frame
During delivery
Title
chorioamnionitis rate
Description
intra-amniotic infection during or after delivery representing in possible combination of maternal fever, fetal tachycardia, maternal leukocytosis, Histopathologic evidence of infection or inflammation or both in the placenta, fetal membranes, or the umbilical cord vessels
Time Frame
During or after delivery up to 7 days
Title
Uterine tachysystole
Time Frame
During delivery
Title
Neonatal morbidity
Description
Apgar score, , ,
Time Frame
After delivery until discharge
Title
Neonatal morbidity
Description
Umbilical Cord Blood Gases
Time Frame
immediately after delivery
Title
Neonatal morbidity
Description
NICU admission
Time Frame
up to 7 days after delivery
Title
Neonatal morbidity
Description
Antibiotic administration
Time Frame
up to 7 days after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women in their 1st - 4th delivery Term prelabor rupture of membranes (37+0 to 42+0 gestational age) Vertex presentation Singleton pregnancy Exclusion Criteria: Multiple pregnancy Previous cesarean section Chorioamnionitis on admission >2 symptomatic uterine contractions in 10 minutes Prostaglandins hypersensitivity Contraindication for vaginal delivery
Facility Information:
Facility Name
Bnai Zion Medical Center
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rami Sammour, MD
Phone
+97248359052
Email
rsammour2002@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Labor Induction With Misoprostol Versus Oxytocin in Women With Premature Rupture of Membranes

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