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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05696574
Other study ID # MS-35-2022
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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
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