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

NCT07526064 | Not Yet Recruiting Phase 1

• 1 other identifier: 27
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Missed Abortion

Keywords

Oral misoprostol; First Trimester; Vaginal misoprostol

Outcome Measures

Primary Outcomes (2)

• Induction to Expulsion Interval

  Induction to expulsion interval is assessed in terms of hours required to expel the conception material.

  48 hours

• Efficacy of Oral Versus Vaginal route

  Efficacy assessed on the basis that no retained conception material in uterus detected on ultrasound after 24 hours of induction

  24 hours

Secondary Outcomes (1)

• Safety of Oral Misoprostol versus Vaginally administered Misoprostol

  48hours

Study Arms (2)

Group A

EXPERIMENTAL

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

Group B

ACTIVE COMPARATOR

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)

Interventions

Oral misoprostol DRUG

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.

Group A

Misoprostol (given vaginally) DRUG

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.

Group B

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hamna Khaliq: lead

Study Sites (1)

PNS Hafeez

Islamabad, 44000, Pakistan

Location

MeSH Terms

Conditions

Abortion, Missed

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Dr Hamna Khaliq, MBBS

CONTACT

+923186333530; hamnakhaliq6@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 13, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)