Propranolol and Misoprostol Versus Misoprostol Alone for Induction of Labor in Primigravidas

Study Overview
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Brief Summary
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To compare propranolol and misoprostol versus misoprostol alone for induction of labour in primigravidas

Detailed Description
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Candidates will be randomized into 2 groups according to a computer generated sequence. Each candidate will be assigned an opaque sealed envelope containing a paper with her group on it. Both the patient and doctor on duty will be blinded to which group the patient was assigned to. - Study procedure: Written informed consent will be obtained from all participants prior to the study. Full history taking. General examination. Patients will be subjected to the following: Patients attending labour room for induction of labour will be divided into two groups. Both groups, women are induced with Tab misoprostol 25μg applied to posterior vaginal fornix under aseptic precaution and every 6 hours for a maximum of 4 doses. In group 1, after induction is started with misoprostol placement, 30 minutes will pass before administration of oral Propanolol 20mg In group 2, after induction is started with misoprostol placement, 30 minutes will pass before administration of oral placebo in the form of sugary tablets. After induction, women will be monitored for fetal and maternal wellbeing and progress of labour.

Official Title
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Propranolol and Misoprostol Versus Misoprostol Alone for Induction of Labor In Primigravidas

Conditions
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Induction of Labor Affected Fetus / Newborn

Intervention / Treatment
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* Drug: Misoprostol
* Drug: Placebo
* Drug: Propranolol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Primigravidas. Full term patients with ultrasound confirmed dates. Singleton. Cephalic presentation. Fetal heart rate between 120 to 160 beats per minute. Exclusion Criteria: • Any history of previous surgery on the uterus. Patients in active labour, with ruptured membranes. Fetal distress. Macrosomia or polyhydramnios Hypersensitivity to prostaglandins. Asthmatic patient . liver or kidney impairment . known cardiac patient with abnormal ECG.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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
Interventional Model Description: Clinical trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Misoprostol + propranolol<br>Patient who receive misoprostol then after 30minutes receive propranolol | Drug: Misoprostol<br>* Pt will receive misoprostol for labor induction then after 30 minutes will receive ether propranolol or misoprostol<br>Drug: Propranolol<br>* Propranolol<br>|
| Placebo Comparator: Misoprostol + placebo<br>Pt who will receive misoprostol then after 30minutes receive placebo | Drug: Misoprostol<br>* Pt will receive misoprostol for labor induction then after 30 minutes will receive ether propranolol or misoprostol<br>Drug: Placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Induction delivery interval | The time from starting induction to the delivery | procedure delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mode of delivery | Vaginal delivery or cesarian section | delivery |