Misoprostol Versus Dinoprostone in Induction of Labor

NCT ID: NCT06909721

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-10
• Study Completion Date: 2024-06-10

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.

Detailed Description

Induction of labor (IOL) is a critical obstetric technique utilized to trigger uterine contractions artificially after fetal viability but prior to the spontaneous onset of labor. It is primarily aimed at achieving cervical effacement and dilatation to facilitate vaginal delivery. This intervention is often necessary in various clinical scenarios, like post-term pregnancies, preeclampsia, gestational diabetes, intrauterine growth restriction, or maternal medical conditions that pose risks to the mother or fetus. Globally, IOL is performed in up to 25% of pregnancies, highlighting its importance in modern obstetrics . In Europe, the rates of IOL vary significantly, ranging from 7% to 33%, reflecting differences in healthcare systems, clinical guidelines, and patient demographics .

The success of IOL is heavily influenced by the condition of cervix at the time of induction. Cervical status is assessed using the Bishop's scoring system, which evaluates factors like cervical dilatation, effacement, consistency, position, and fetal station. A favorable cervix, characterized by a Bishop's score of 6 or higher, is related to an elevated probability of successful vaginal delivery. In contrast, an unfavorable cervix (posterior, firm, and long) presents significant challenges, decreasing the chances of vaginal birth and increasing the risk of cesarean delivery.

Cervical ripening is a fundamental process that prepares the cervix for labor by increasing its softness and distensibility. This process is controlled by a complex interplay of hormonal, biochemical, vasodilatory and inflammatory alterations. Endogenous prostaglandins (PGs), produced by uterus, cervix, fetal membranes and placenta, have a pivotal role in these changes. PGs stimulate the breakdown of collagen fibers, increase water content, and promote the release of cytokines and other inflammatory mediators that facilitate cervical remodeling. When natural ripening is insufficient, iatrogenic methods are employed to induce cervical ripening and labor. These methods include mechanical agents, such as Foley catheters, cervical dilators, or amniotomy, and pharmacological agents, such as prostaglandins, oxytocin, and smooth muscle stimulants like herbs or castor oil.

Despite its widespread use, IOL is not without risks. Common challenges include ineffective labor induction, prolonged labor, and excessive uterine activity, which may result in complications like fetal distress, uterine rupture, and an elevated probability of cesarean delivery. Prostaglandins, which mediate their effects through specific G protein-coupled receptors (GPCRs), are integral to the inflammatory and immune responses that drive cervical ripening .

However, the therapeutic utilization of natural PGs is restricted by their quick metabolism, chemical instability, and short half-life, as well as their propensity to cause side effects like vomiting, diarrhea, nausea, and uterine hyperstimulation .

To overcome these limitations, synthetic prostaglandins have been developed and are widely used in clinical practice. Misoprostol, a synthetic analog of prostaglandin E1 (PGE1), is the most frequently utilized agent due to its stability, cost-effectiveness, and ease of administration. It is available in oral, sublingual, and vaginal forms, making it a versatile option for labor induction. Misoprostol is particularly effective in low-resource settings because of its affordability and stability at room temperature. However, its use requires careful dosing to avoid complications such as uterine hyperstimulation and fetal distress .

Dinoprostone, a synthetic analog of prostaglandin E2 (PGE2), is another widely used agent, particularly in settings where controlled release and fewer side effects are desired. Dinoprostone is available in gel, insert, and suppository forms, allowing for tailored dosing based on individual patient needs. It is often preferred in cases where a slower, more controlled induction process is warranted. However, dinoprostone is more expensive than misoprostol and requires refrigeration, which can limit its use in resource-constrained settings.

Conditions

Induction of Labor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Misoprostol Group

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

Group Type: ACTIVE_COMPARATOR

Misoprostol

Intervention Type: DRUG

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

Dinoprostone Group

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

Group Type: ACTIVE_COMPARATOR

Misoprostol

Intervention Type: DRUG

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

Interventions

Misoprostol

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

Intervention Type: DRUG

Other Intervention Names

Dinoprostone

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

Shaimaa Elkhodary Hassan

Resident of Obstetrics & Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mahmoud Ebrahim Al Rashidi, Professor

Role: STUDY_CHAIR

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

Locations

Al-Azhar University Hospitals

Asyut, Assuit, Egypt

Countries

Egypt

Other Identifiers

Shaimaa Elkhodary

Identifier Type: -

Identifier Source: org_study_id