Termination of Pregnancy in Previous Scarred Uterus: PGE1 Versus Cervical Folleys

NCT07604051 | Completed Phase 4 DMC

• 1 other identifier: Hilal-e-Ahmer Hospital
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

As mentioned above, previous studies have shown variable results and the best among these two is still in debate, so there must be re-evaluation of results on this topic. The rationale of this study is to compare the efficacy (in terms of complete evacuation) of PGE1 versus cervical folleys in termination of pregnancy. This study not only will lead to the decision regarding selection of appropriate method with less comorbidities but also add in the literature regarding the women health improvement that is a matter of concern in 21st century. Then based on the results of my study, these particular patients can be provided with better way of second trimester termination of pregnancy in order to reduce the complications of the incomplete miscarriage as well as morbidity and mortality of these patients

Conditions

Termination of Pregnancy

Keywords

PGE1; cervical folleys; termination of pregnancy

Outcome Measures

Primary Outcomes (1)

• Percentage of efficacy

  It refers to the ability of PGE1 or cervical Foleys to achieve complete abortion within 48 hours during the second trimester of fetal demise

  48 hours

Study Arms (2)

PGE1

EXPERIMENTAL

Group A will receive 200µg orally five doses six hours apart. If the patient did not abort after the first course, the same regimen will be repeated 24 hours after the start of the first dose of misoprostol

Drug: PGE1 tablet

cervical folleys

ACTIVE COMPARATOR

Group B will receive cervical foleys. Foley's catheter group will be put in lithotomy position in examination room, vulva vagina will be cleaned with pyodine and sterile Sim's speculum will be introduced in the vagina, holding anterior cervical lip with sponge holding forceps and with the help of another sponge holding forceps a Foleys catheter no 14 Fr will be passed in the cervix into the extra amniotic space and balloon will be inflated with 30ml saline. A urine bag will be filled with 500ml saline will be attached to the catheter for traction. As soon as the catheter will be expelled reassessment of the dilatation of the cervix will be done and if needed infusion oxytocin will be started

Device: cervical folleys

Interventions

PGE1 tablet DRUG

Group A will receive 200µg orally five doses six hours apart. If the patient did not abort after the first course, the same regimen will be repeated 24 hours after the start of the first dose of misoprostol

PGE1

cervical folleys DEVICE

Group B will receive cervical foleys. Foley's catheter group will be put in lithotomy position in examination room, vulva vagina will be cleaned with pyodine and sterile Sim's speculum will be introduced in the vagina, holding anterior cervical lip with sponge holding forceps and with the help of another sponge holding forceps a Foleys catheter no 14 Fr will be passed in the cervix into the extra amniotic space and balloon will be inflated with 30ml saline. A urine bag will be filled with 500ml saline will be attached to the catheter for traction. As soon as the catheter will be expelled reassessment of the dilatation of the cervix will be done and if needed infusion oxytocin will be started

cervical folleys

Eligibility Criteria

• Age: 20 Years - 45 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• All women presented for termination of pregnancy (as per-operational definition).
• Patients with age 20-45 years

You may not qualify if:

• Women having multiple gestation.
• Women having any complication of miscarriage like bleeding, chorioamnionitis, disseminated intravascular coagulopathy.
• Women having any complication in previous cesarean like endometritis, re opening and scar dehiscence.
• Patients with molar or ectopic pregnancy (assessed on ultrasonography).

Sponsors & Collaborators

• Dr Mudassar Saeed Pansota: lead

Study Sites (1)

Hilal-e-ahmar Hospital

Faisalabad, Punjab Province, 60000, Pakistan

Location

MeSH Terms

Interventions

Alprostadil

Intervention Hierarchy (Ancestors)

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

Study Officials

• Atiqa Noreen

  Hilal-e-Ahmar Hospital, Faisalabad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 17, 2026
• First Posted: May 22, 2026
• Study Start: November 13, 2025
• Primary Completion: April 12, 2026
• Study Completion: May 12, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

PA (1)