Comparison of Efficacy and Safety of Oral Versus Vaginal Misoprostol in Missed Abortion in First Trimester of Pregnancy

April 6, 2026 updated by: Hamna Khaliq

Incomplete abortion has an eminent clinical diagnosis and is characterized by transvaginal bleeding associated with an open uterine cervix upon physical examination when the products of conception have not been wholly discharged. This is the most frequent clinical presentation of this condition. Currently, misoprostol (prostaglandin E2 analog), along with mifepristone, is the reference drug for medicated uterine emptying in cases of spontaneous or induced abortion, both in the first gestational trimester and at more advanced gestational ages.Misoprostol-only is a safe and effective option for females with missed abortion in the first trimester, although less effective than standard regimens that also contain mifepristone.Once the efficacy, safety, and acceptability of misoprostol in incomplete abortion are well established, future studies must be done in finding the ideal route of administration (oral, sublingual, or vaginal), perfect dosage, and intervals of administration when necessary.

The purpose of this study is to evaluate the safety and effectiveness of oral versus vaginal misoprostol in cases of missed abortions during the first trimester of pregnancy. Misoprostol is widely used for medical management of early pregnancy loss; however, the optimal route of administration remains uncertain. Comparing these two routes may help identify the most effective and safest method, thereby improving patient outcomes and guiding clinical practice. According to literature, misoprostol administered vaginally has better effectiveness and fewer side effects. However, conflicting evidence has been found in literature that indicates there is no difference between both route for misoprostol administration. In order to determine the best course of action with the fewest adverse effects for women who have missed an abortion, we wish to carry out this experiment. In order to apply the more appropriate route to the local community, adopt a more effective approach, and revise the criteria for doing so. This will enhance our expertise and methods as well as will improve patients' satisfaction will treatment.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
      • Islamabad, Pakistan, 44000
        • PNS Hafeez
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Parity <5
  • Presenting with missed abortion (defined as spontaneous loss of pregnancy, presence of lower abdomen cramps, ultrasound scan shows no fetal cardiac activity during 8-16 weeks of pregnancy)

Exclusion Criteria:

  • Pregnancy with any degree of cervical dilatation
  • Signs or symptoms of infection,
  • Twin gestation sac, molar pregnancy (on ultrasound),
  • Excessive uterine bleeding,
  • Blood pressure ≥160/90 mmHg,
  • Maternal history of asthma or cardiac or cerebral disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
After obtaining informed consent and demographic information, anemia, previous abortion, use of intrauterine contraceptive device, history of taking hormonal treatment, in-vitro fertilization) will be recorded. Then females will be randomly divided in two groups by using lottery method. In group A, 50 females will be given 400 µg Misoprostol orally, maximum of 3 doses.Then females will be followed-up in labor room until expulsion of conception material Induction to expulsion interval will be noted. After expulsion, females will undergo ultrasonography by a senior sonologist with assistance of researcher. If there will be no retained conception material in uterus, then efficacy will be labeled. Females will be shifted to post-delivery wards and will be followed-up there for 48 hours for assessment of any adverse effect including nausea, vomiting, headache, diarrhea,fever and rash. All this Information will be recorded in proforma.
Drug: Oral misoprostol
In group A, females will be given 400 µg orally, maximum of 3 doses.Females will be shifted to post-delivery wards and will be followed-up there for 48 hours for assessment of any adverse effect.
Active Comparator: Group B
After obtaining informed consent and demographic information, anemia, previous abortion, use of intrauterine contraceptive device, history of taking hormonal treatment, in-vitro fertilization) will be recorded. Then females will be randomly divided in two groups by using lottery method. In group B, 50 females will be given 400 µg Misoprostol vaginally at maximum of 3 doses.Then females will be followed-up in labor room until expulsion of conception material Induction to expulsion interval will be noted. After expulsion, females will undergo ultrasonography by a senior sonologist with assistance of researcher. If there will be no retained conception material in uterus, then efficacy will be labeled. Females will be shifted to post-delivery wards and will be followed-up there for 48 hours for assessment of any adverse effect including nausea, vomiting, headache, diarrhea,fever and rash. All this Information will be recorded in proforma.
Drug: Misoprostol (given vaginally)
In group B, females will be given 400 µg vaginally, maximum of 3 doses.Females will be shifted to post-delivery wards and will be followed-up there for 48 hours for assessment of any adverse effect.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Induction to Expulsion Interval
Time Frame: 48 hours
Induction to expulsion interval is assessed in terms of hours required to expel the conception material.
48 hours
Efficacy of Oral Versus Vaginal route
Time Frame: 24 hours
Efficacy assessed on the basis that no retained conception material in uterus detected on ultrasound after 24 hours of induction
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of Oral Misoprostol versus Vaginally administered Misoprostol
Time Frame: 48hours
Safety is assessed in terms of absence of any adverse event including nausea and vomiting (>3 episodes per week), headache, diarrhea (>3 loose stools), fever (>100oF), and rash (redness and itching on skin)
48hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamna Khaliq

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

April 6, 2026

First Submitted That Met QC Criteria

April 6, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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