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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04533841
Enrollment
128
Registered
2020-09-01
Start date
2020-02-01
Completion date
2020-09-15
Last updated
2022-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Induction of Labor Affected Fetus / Newborn

Brief summary

To compare propranolol and misoprostol versus misoprostol alone for induction of labour in primigravidas

Detailed description

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: 1. Written informed consent will be obtained from all participants prior to the study. 2. Full history taking. 3. 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.

Interventions

DRUGMisoprostol

Pt will receive misoprostol for labor induction then after 30 minutes will receive ether propranolol or misoprostol

DRUGPlacebo

placebo

DRUGPropranolol

Propranolol

Sponsors

Ain Shams University
CollaboratorOTHER
Ahmed mohamed fathy ismail
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Double blinded research

Intervention model description

Clinical trial

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Induction delivery intervalprocedure deliveryThe time from starting induction to the delivery

Secondary

MeasureTime frameDescription
Mode of deliverydeliveryVaginal delivery or cesarian section

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026