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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Prelabor Rupture of Membranes, Premature Rupture of Membrane

Intervention / Treatment
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* Drug: Misoprostol
* Drug: Oxytocin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: misoprostol<br>misoprostol 50 mcg tablet by mouth every four hours for maximum dosage of six | Drug: Misoprostol<br>* Oral administration of cytotec every 4 hours until a maximum of 6 doses<br>* Other names: PGE1;|
| Active Comparator: oxytocin<br>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) | Drug: Oxytocin<br>* Intravenous infusion of Pitocin through an IVAC until delivery<br>* Other names: Pitocin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal delivery rate |  | During delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative delivery rate, Cesarean section rate, time interval from induction of labor to delivery |  | During 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 | During or after delivery up to 7 days | 
| Uterine tachysystole |  | During delivery | 
| Neonatal morbidity | Apgar score, , , | After delivery until discharge | 
| Neonatal morbidity | Umbilical Cord Blood Gases | immediately after delivery | 
| Neonatal morbidity | NICU admission | up to 7 days after delivery | 
| Neonatal morbidity | Antibiotic administration | up to 7 days after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PROM