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

Ahmed mohamed fathy ismail

Status and phase: Completed; Phase 2

Conditions: Induction of Labor Affected Fetus / Newborn

Treatments: Drug: Propranolol; Drug: Placebo; Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT04533841

Ahmed mohamed fathy ismail

Details and patient eligibility

About

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

Full 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:

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.

Enrollment: 128 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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128 participants in 2 patient groups, including a placebo group

Misoprostol + propranolol

Active Comparator group

Description:

Patient who receive misoprostol then after 30minutes receive propranolol

Treatment:

Drug: Misoprostol

Drug: Propranolol

Misoprostol + placebo

Placebo Comparator group

Description:

Pt who will receive misoprostol then after 30minutes receive placebo

Treatment:

Drug: Misoprostol

Drug: Placebo