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NCT Number: NCT07604051

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

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

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Key information

Conditions

Termination of Pregnancy

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Hilal-e-ahmar Hospital

Faisalabad, Punjab Province, 60000, Pakistan

About this study

Among unintended 205 million pregnancies that occur each year worldwide, about 20% of them end in induced abortion. Majority of these abortions occur during the first trimester of pregnancy. The second trimester of pregnancy is subdivided into an early period between 13-20 weeks and a late period between 20-28 weeks. Advanced screening techniques have led to an increase in the detection of congenital malformations with subsequent gradual increase in second trimester termination of pregnancy which represents 10-15% of total abortions performed worldwide. Termination in the second trimester is more risky than during first trimester. So the pharmacologic management seems to be an appealing alternative to surgical evacuation.

There is a wide range of prostaglandin preparations available which can be used for cervical ripening or induction of labour. Misoprostol is a synthetic prostaglandin E1 analogue. It was first used in obstetrics to induce abortion in 1988. Now it is widely used for induction of labour, termination of pregnancy and management of postpartum haemorrhage but still its use in obstetrics is not approved by FDA. Mechanical dilatation of cervix to induce abortion or labour is also known since 1833. The Foleys catheter traction is the cheapest, safest and successful mechanical method of cervical dilatation according to various studies. The decision regarding the effectiveness of any of the above two modality in women with previous cesarean is still a debate

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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).

Treatment and study plan

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

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

Primary outcomes

  1. Percentage of efficacy

    Time frame: 48 hours

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

Sponsors and collaborators

Lead sponsor

Dr Mudassar Saeed Pansota

Other

Registry information

Official study title

Comparison of the Efficacy of PGE1 Versus Cervical Folleys in Termination of Pregnancy in Previous Scarred Uterus

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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