Comparative Study Between Only Vaginal Misoprostol and Vaginal Misoprostol and Estradiol Cream

Comparative Study Between Using Only Vaginal Misoprostol and Using Vaginal Misoprostol and Estradiol Cream for Induction of Labour

To compare the safety and effectiveness of vaginal misoprostol with combined vaginal misoprostol and estradiol for induction of labour in unfavorable cervix

Study Overview

• Status: Recruiting
• Conditions: Cervix; Pregnancy
• Intervention / Treatment: Drug: Vaginal Tablet

Detailed Description

Induction of labour (IOL) is the process of initiating contractions of pregnant persons who are currently not in labour, to help them achieve vaginal delivery within 24 to 48 hours. Cervical ripening is one of the methods that used for labour induction; it is "the use of pharmacological or other means to soften, efface, or dilate the cervix to increase the likelihood of a vaginal delivery". The two major techniques for cervical ripening are mechanical interventions (e.g. insertion of balloon catheters), and application of pharmacological agents (e.g. prostaglandins). Prostaglandins are one of the preferred methods for cervical ripening, including the agents dinoprostone and misoprostol

. By the mid of-1980s prostaglandins had become established as the most effective pharmacological agents for inducing labour when the cervix is unripped. The vaginal route was found to be the most acceptable, providing good efficacy and acceptability for the parturient and it is the preferred choice now.

During the past 15 years the introduction of misoprostol, the prostaglandinsE1(PGE1) which, unlike prostglandinsE2 (PGE2), is stable at room temperature and it is effective if it was taken orally, has been the major focus of attention for labour induction. It is also considerably cheaper than the alternative prostaglandin.

With the ever-increasing concentrations of estrogen in the maternal circulation leading to term pregnancy, the belief that this could be a trigger for the onset of spontaneous labour led the studies to explore estrogens for the induction of labour.

Estradiol gel gives extra--amniotic, endocervical or vaginally or estradiol intramuscularly and estradiol gel extra-amniotic have been shown to produce some improved cervical favorability with minimal myometrial stimulation.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Amira M Ahmed, MSC; Phone Number: +201090904528; Email: dr_amiramaher@yahoo.com
• Study Contact Backup: Name: Rania G Anwar, Lecturer; Phone Number: +2012832627054; Email: dr.raniagamal2015@yahoo.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Ain Shams University
    • Contact: .Fekria A Salama, Professor; Phone Number: +201092934978; Email: dr_amiramaher@yahoo.com
    • Contact: Mortada S Ahmed, Professor; Phone Number: +201001267054; Email: Mortada.elsayed80@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Gestational age36:41 weeks.
• Singleton pregnancy.
• Absence of labour pain.
• Living fetus with cephalic presentation.
• Fetal weight < 4 k.gs.
• No previous uterine surgical procedures.
• No liquor abnormalities.
• Bishop score < 5.

Exclusion Criteria:

• - Multiple gestations. one of the contraindications of induction of labor as it may cause rupture of the uterus.
• Liquor abnormalities.one of contraindications of induction of labor as it may cause fetal distress.
• Abnormal umbilical artery Doppler indices or non-stress test as these indicate fetal distress.
• Fetal weight > 4 kgs.as macrosomia is an indication of caesarean section for fear of shoulder dystocia .
• Previous uterine surgery.contraindication of labor induction for fear of rupture uterus.
• Asthmatic patient or women with allergy to prostaglandins or steroidal.
• Non-vertex presentation.contraindication of labor induction as it may cause rupture uterus.
• Fetal or maternal complications that might cause cesarean section.
• Intrauterine fetal death.often induction of labor in women with a dead fetus is performed before term when the uterus may be less responsive to uterotonics than it is at term and this will affect the results of the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: vaginal misoprostol; only vaginal misoprostol 25 μg tablets will be applied for induction of laour	Drug: Vaginal Tablet; Misoprostol alone will be repeated every 4 h in both groups for a maximum of 5 doses, reaching Bishop score >8, rupture of membranes or occurrence of labor pain. Cervical evaluation will be done using Bishop's score. A score < 5 will be taken as unfavorable Cervix will be termed as ripped when Bishop's score equal 8 or more. The endpoint of the study will be initiation of active phase of 1st stage of labor which commence from 6cm to full cervical dilatation; Other Names: vaginal misoprostol and vaginal estradiol
Active Comparator: combined vaginal misoprostol and estradiol; vaginal misoprostol 25 μg (Vagiprost) tablets with vaginal estradiol 150 ml cream will be applied for induction of laour	Drug: Vaginal Tablet; Misoprostol alone will be repeated every 4 h in both groups for a maximum of 5 doses, reaching Bishop score >8, rupture of membranes or occurrence of labor pain. Cervical evaluation will be done using Bishop's score. A score < 5 will be taken as unfavorable Cervix will be termed as ripped when Bishop's score equal 8 or more. The endpoint of the study will be initiation of active phase of 1st stage of labor which commence from 6cm to full cervical dilatation; Other Names: vaginal misoprostol and vaginal estradiol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Induction of labour with closed cervix	assessment of uterine contractions and cervical opening of the pregnant females who are currently not in labour, to help them to reach normal vaginal delivery process.	from 0 hours to 14 hours after induction of labour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Whole Delivery time after induction of labour.	The whole time from induction to the end of vaginal labour with complications that may arise as: -uterine hyperstimulation, postpartum hemorrhage, rupture of the uterus and neonatal morbidity, fetal distress, and fetal hypoxia.	from 0 hours to the end of the delivery

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2022
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): August 30, 2022

Study Registration Dates

• First Submitted: February 18, 2022
• First Submitted That Met QC Criteria: March 23, 2022
• First Posted (Actual): April 1, 2022

Study Record Updates

• Last Update Posted (Actual): April 1, 2022
• Last Update Submitted That Met QC Criteria: March 23, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: cervical dilatation, Uneffaced cervix, closed os
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Estrogens; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Estradiol; Misoprostol
• Other Study ID Numbers: 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No