Oral and Vaginal Misoprostol for Induction of Labor in Nulliparous Pregnant Women

Pregnancy Clinical Trial

Official title:

Comparative Study Between Oral and Vaginal Misoprostol for Induction of Labor in Nulliparous Pregnant Women at or Beyond Completed 41 Weeks

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05696574
• Other study ID #: MS-35-2022
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 20, 2023
• Est. completion date: June 20, 2023

Study information

• Verified date: January 2023
• Source: Cairo University
• Contact: Elsayed F. Omran, M.B.B.CH
• Phone: 1032205090
• Email: mahmoudhamdy2251988[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare the efficacy and the safety of vaginal misoprostol with oral misoprostol for induction of labor in nulliparous pregnant women at or beyond completed 41 weeks.

Description:

Induction of labor is carried out for maternal and fetal indications and one of the most common indications is prolonged pregnancy. Recent studies have suggested that by continuing pregnancy beyond 41 weeks, there is statistically significantly higher perinatal morbidity and mortality as well as an increased risk to the mother. Thus, there is a growing body of evidence suggesting the elective induction of labor at 41 weeks of gestation instead of expectant management. Misoprostol, a prostaglandin E1 analog, is indicated for protection against gastric ulcers, but when administered prenatally it causes uterine contractions. Research exploiting this adverse effect has shown misoprostol to be superior to conventional methods for induction, resulting in shorter induction-to-delivery intervals, without any increase in adverse outcomes. It has the advantage of being cheap, stable at room temperature, and easy to be administered by various routes i.e., vaginal, oral, sublingual, or rectal. The differential outcomes of oral versus vaginal misoprostol may be secondary to different pharmacokinetics for oral compared with vaginal misoprostol. Oral misoprostol undergoes rapid absorption from the gastrointestinal tract and rapid and extensive de-esterification during first-pass metabolism to an active metabolite, misoprostol, peaking at 15 minutes with a half-life of 20-40 minutes. Misoprostol then undergoes early rapid elimination over 120 minutes, followed by slow elimination thereafter. The medication rapidly makes its way to the myometrium. ln contrast, after vaginal misoprostol administration, plasma concentration gradually increase, reaching a maximum level after 70-80 minutes before slowly being eliminated with plasma levels still detectable 6 hours after administration.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: June 20, 2023
• Est. primary completion date: June 20, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

1. Maternal age: 18-40.

2. Nullipara: a woman who has never completed a pregnancy beyond 20 weeks gestation. She may not have been pregnant or may have had a spontaneous or elective abortion(s) or an ectopic pregnancy.

3. Single living pregnancy.

4. Gestational age: at or beyond completed 41 weeks (confirmed by a reliable date for the last menstrual period, regular cycle, or/and 1st trimesteric ultrasound scan).

5. Cephalic presentation.

6. Bishop score of 6 or less.

7. Reactive fetal non-stress test (NST).

Exclusion Criteria:

1. Any maternal chronic diseases or pregnancy-induced medical disorders.

2. Fetal anomalies.

3. Fetal macrosomia (>4 Kg).

4. Intrauterine Growth Restriction (IUGR) (EFW below the 10th percentile for gestational age).

5. Rupture of membranes or oligohydramnios (AFI < the fifth percentile).

6. Previous uterine scar.

7. Regular uterine contractions.

8. Any contraindication to vaginal delivery e.g., placenta previa (complete or partial covering of the internal os of the cervix with the placenta).

Related Conditions & MeSH terms

• Labor
• Misoprostol
• Nulliparous
• Pregnancy

Intervention

Drug:
• Vaginal Misoprostol
Women in this group will include 40 pregnant women who will be offered misoprostol (placed in the post-fornix of the vagina) in a dose of 25µg to be repeated every 6 hours if no response is achieved with a maximum of 4 doses.
• Oral Misoprostol
Women in this group will include 40 pregnant women who will be offered oral misoprostol in a dose of 25µg to be repeated every 6 hours if no response is achieved with a maximum of 4 doses.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Onset of active stage of labor	Duration to onset of active stage of labor	24 hours postoperatively
Secondary	Cesarean section rate in each group	Cesarean section rate will be recorded	Within 24 hours from drug induction
Secondary	Doses given	Number of durg doses given will be recored	Intraoperativley
Secondary	Augmentation need	Number of participants need for labor augmentation with oxytocin and/or amniotomy will be evaluated	Intraoperatively
Secondary	Complications	Any complications will be recorded	48 hours Postoperatively