Misoprostol Versus Dinoprostone in Induction of Labor

NCT06909721 | Completed DMC

• 1 other identifier: Shaimaa Elkhodary
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Endogenous prostaglandins, derived from the uterus, cervix, placenta, and membranes of fetus, are essential for cervical ripening ,the investigators aimed to compare Misoprostol and Dinoprostone as regarding to cost-effectiveness and safety in induction of Labor. Both misoprostol and dinoprostone have demonstrated efficiently in cervical ripening and labor induction. However, their use must be carefully monitored to minimize risks and optimize outcomes. Factors such as parity, gestational age, maternal medical history, and the indication for induction should be considered when selecting the most appropriate induction method. Additionally, patient preferences and institutional protocols play a role in decision-making. Recent advancements in IOL techniques include the use of combination methods, like mechanical and pharmacological agents, to enhance efficacy and reduce complications. For example, the combination of a Foley catheter with low-dose misoprostol has been shown to improve cervical ripening and reduce the time to delivery . Additionally, the development of new pharmacological agents, such as misoprostol vaginal inserts and controlled-release dinoprostone gels, offers promising alternatives for safe and effective labor induction.

Conditions

Induction of Labor

Outcome Measures

Primary Outcomes (2)

• Induction of Labor

  Assessment of labour induction by the using the modified Bishop score . The bishop score evaluated cervical readiness for labor induction by examining five components: cervical consistency, cervical dilation, station of the baby, cervical position, and cervical length. Cervical dilation measured the opening of the cervix on a scale from 0 (no dilation) to 3 (≥5 cm). Cervical consistency assessed the texture of the cervix, scored from 0 (firm) to 2 (soft). Cervical position was rated from 0 (posterior) to 2 (anterior). The baby's station was scored from -3 (high in the pelvis) to +3 (deeply engaged). Cervical length was evaluated on a scale from 0 (≥3 cm) to 2 (\<2 cm). These components were combined to produce a total Bishop score varying from 0 to 13.

  48 hours after drug administration

• Induction of Labor

  Assessment of labour induction by the using the Apgar score. The Apgar score, performed at one and five minutes after birth, assessed the newborn's condition across five factors: respiratory effort, heart rate, reflex irritability, tone of muscle, and color of skin, with each scored from zero to two. Heart rate was rated as 2 if it exceeded 100 beats per minute, 1 if below 100, and 0 if absent.

  just after delivery

Study Arms (2)

Misoprostol Group

ACTIVE COMPARATOR

About 100 pregnant women received Misoprostol vaginal tablets (25-50 mcg every 6 Hours for 4 doeses and re use after 48 hour) for induction of normal labour

Drug: Misoprostol

Dinoprostone Group

ACTIVE COMPARATOR

About 100 pregnant women received Dinoprostone vaginal tablets (3mg vaginal tablets, one tablet to be inserted high in posterior fornix and the second tablet inserted after 8 hour if labour not established with maximum does 6 mg) for induction of normal labour

Drug: Misoprostol

Interventions

Misoprostol DRUG

to compare Misoprostol and Dinoprostone as regarding to cost-effectiveness and safety in induction of normal Labor

Also known as: Dinoprostone

Dinoprostone Group; Misoprostol Group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Singleton pregnancy
• Intact membranes
• Bishop score 4-6 or less
• Women accepted to participate in the study
• Indicated patient of induction 39WeeKs of pregnancy or more

You may not qualify if:

• Fetal congenital anomalies
• malpresentation
• irregular fetal heart rate patterns
• placental abnormalities, and any contraindications to administering prostaglandins
• involving a history of glaucoma, asthma, cardiovascular disease or preexisting cardiac
• prior uterine operation, cesarean delivery
• maternal chronic illness

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al-Azhar University Hospitals

Asyut, Assuit, Egypt

Location

MeSH Terms

Interventions

Misoprostol; Dinoprostone

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Prostaglandins E

Study Officials

• Mahmoud Ebrahim Al Rashidi, Professor

  Obstetrics and Gynecology Department, Faculty of medicine,Al-Azhar University, Assiut.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Obstetrics & Gynecology

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: April 3, 2025
• Study Start: June 10, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 10, 2024
• Last Updated: April 3, 2025

Record last verified: 2023-06

Locations

EG (1)