Prelabor Rupture of Membranes Clinical Trial
Official title:
Oxytocin Versus Oral Misoprostol for Induction of Labor in Pregnant Women With Term Prelabor Rupture of Membranes
Verified date | June 2022 |
Source | Ain Shams Maternity Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of study is to compare the efficacy and safety of oral misoprostol versus oxytocin in induction of labor in pregnant women with prelabor rupture of membranes at term.
Status | Completed |
Enrollment | 200 |
Est. completion date | May 16, 2022 |
Est. primary completion date | January 15, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: - Gestational age (36-42 weeks). - Prelabor rupture of membranes within the last 24hours - Vertex presentation Exclusion Criteria: 1. History of medical diseases (HTN, diabetes milletus, systemic lupus erythematosus, cardiac, etc.). 2. Antepartum hemorrhage 3. Chorioamnionitis / prelabor rupture of membranes >24hours 4. Multiple pregnancy. 5. Abnormal fetal heart rate pattern upon admission 6. Intrauterine growth restriction 7. Fetal malpresentation. 8. Previous uterine scar. 9. Estimated fetal weight more than 4kg. 10. Patients already in labor 11. Contraindication for prostaglandin/oxytocin use (allergy,..) |
Country | Name | City | State |
---|---|---|---|
Egypt | Ain Shams Maternity Hospital | Cairo |
Lead Sponsor | Collaborator |
---|---|
Ain Shams Maternity Hospital |
Egypt,
Alfirevic Z, Aflaifel N, Weeks A. Oral misoprostol for induction of labour. Cochrane Database Syst Rev. 2014 Jun 13;(6):CD001338. doi: 10.1002/14651858.CD001338.pub3. Review. — View Citation
Zeteroglu S, Engin-Ustün Y, Ustün Y, Güvercinçi M, Sahin G, Kamaci M. A prospective randomized study comparing misoprostol and oxytocin for premature rupture of membranes at term. J Matern Fetal Neonatal Med. 2006 May;19(5):283-7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | vaginal delivery | rate of successful vaginal delivery | immediately after the intervention | |
Secondary | induction to active phase time | Time interval from starting induction till active phase (6cm dilatation) | during the intervention | |
Secondary | Induction to delivery time | Time interval from starting induction till delivery | during the intervention | |
Secondary | Apgar score | This scoring system provides a standardized assessment for infants after delivery. The Apgar score comprises five components: 1) color, 2) heart rate, 3) reflexes, 4) muscle tone, and 5) respiration, each of which is given a score of 0, 1, or 2. | The score is reported at 1 minute and 5 minutes after birth for all infants | |
Secondary | NICU admission | number of newborns admitted to the neonatal intensive care unit | within 24hours after birth | |
Secondary | maternal side effects | number of participants with temperature >38 degree celsius | during labour and within 24hours after birth |
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