Oral Misoprostol Solution in Labor Induction

A Comparison of the Efficacy and Safety of Repetitive Hourly Dose of Oral Misoprostol and Two Hourly Dose Oral Regimens for Cervical Ripening and Labor Induction

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03927807

Enrollment

150

Registered

2019-04-25

Start date

2019-03-18

Completion date

2020-01-18

Last updated

2019-04-25

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

Conditions

Labour,Induced

Keywords

misoprostol

Brief summary

This study compares safety and efficacy between repetitive hourly dose of oral misoprostol and two hourly dose oral regimens for cervical ripening and labor induction.

Detailed description

Misoprostol is an effective agent for the induction of labor.existing guidelines recommend oral misoprostol solution every two hours.However,more research is required to optimize the use of oral misoprostol solution for labor induction.The current study is to compare efficacy and safety of repetitive hourly dose of oral misoprostol solution with two hourly dose of oral misoprostol solution for cervical ripening and labor induction.

Interventions

DRUGMisoprostol

This study will include 150 pregnant women who fulfill the inclusion criteria and will be subdivided in two groups. Group1 will receive repetitive hourly dose of oral misoprostol solution equal to 10 microgram up to 12 doses or regular uterine activity. Group2 will receive oral misoprostol solution every two hours as 20 microgram up to 6 doses or regular uterine activity.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Yes

Inclusion criteria

* Nulliparas * Term pregnancy(equal or more than 37 wks) * Bishop score \<6 * Cephalic presentation * reassuring fetal heart rate pattern * Not in labor ( no uterine contractions) * Clinically adequate pelvis * Singleton live pregnancy

Exclusion criteria

* Allergic to misoprostol or prostaglandin analogues * Previous uterine scar( cesarean section,hysterotomy,myomectomy) * Multiple fetal gestations * Fetal demise * Preterm labor * Malpresentations * Non reactive cardiotocography at admission * Cephalo pelvic disproportion * Fetal macrosomia

Design outcomes

Primary

Measure	Time frame	Description
Mode of delivery	24 hours from the first dose of induction till delivery	Successful vaginal delivery within 24 hours from starting induction of labor or cesarean section delivery after failed trial of induction.

Secondary

Measure	Time frame	Description
Adverse maternal outcomes	in 24 hours	As uterine hyper stimulation,fever,vomiting,shivering,nausea
Adverse neonatal outcomes	24 hours post partum	As neonatal intensive care unit admission,non reassuring fetal heart rate

Countries

Egypt

Contacts

Primary Contactessam sa hagag, MBBCh

essamhagag742@yahoo.com01066813830

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026