---
title: Sublingual Versus Vaginal Misoprostol In Medical Treatment of First Trimestric Missed Miscarriage
nct_id: NCT02686840
overall_status: COMPLETED
phase: PHASE3
sponsor: Ain Shams University
study_type: INTERVENTIONAL
primary_condition: Missed Abortion
countries: Egypt
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02686840.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02686840"
ct_last_update_post_date: 2017-08-16
last_seen_at: "2026-05-12T06:02:47.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Sublingual Versus Vaginal Misoprostol In Medical Treatment of First Trimestric Missed Miscarriage

**Official Title:** Sublingual Versus Vaginal Misoprostol In Medical Treatment of First Trimestric Missed Miscarriage: A Randomized Controlled Trial.

**NCT ID:** [NCT02686840](https://clinicaltrials.gov/study/NCT02686840)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 200
- **Lead Sponsor:** Ain Shams University
- **Conditions:** Missed Abortion
- **Start Date:** 2016-01
- **Completion Date:** 2017-03
- **CT.gov Last Update:** 2017-08-16

## Brief Summary

The aim of this work is to compare the effectiveness of vaginal versus sub-lingual misoprostol for medical treatment of first trimester missed miscarriage.

## Detailed Description

In women with first trimetric-missed miscarriage, sublingual misoprostol may be as vaginal misoprostol in achievement of successful miscarriage so our aim was to compare the effectiveness of vaginal versus sub-lingual misoprostol for medical treatment of first trimester missed miscarriage.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 40 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* All women above 18 years of age
* Less than 12 weeks of gestation.
* Pregnancy is confirmed by pregnancy test or ultrasound scan.
* missed abortion
* Normal general and gynecological examination.
* The size of the uterus on pelvic examination was compatible with the estimated duration of pregnancy

Exclusion Criteria:

* Hemodynamically unstable.
* Suspected sepsis with temperature 38 °C.
* Concurrent medical illness e.g. hematological, cardiovascular, thromboembolism, respiratory illnesses, recent liver disease or pruritus of pregnancy.
* Presence of intrauterine contraceptive device (IUCD).
* Suspect or proven ectopic pregnancy.
* Failed medical or surgical evacuation before presentation.
* Known allergy to misoprostol.
```

## Arms

- **sublingual misoprostol** (EXPERIMENTAL) — Group A (100 patients): will be treated with sublingual misoprostol
- **vaginal misoprostol** (ACTIVE_COMPARATOR) — Group B (100 patients): will be treated with vaginal misoprostol

## Interventions

- **sublingual misoprostol** (DRUG) — All patients will receive three doses of sublingual misoprostol every four hours The first dose of misoprostol 800 mcg will be administrated at the hospital. Then the patient will be observed for 1 hour for any immediate adverse reaction Clear instructions about the method and timing of second dose will be given upon sending home.

* Two doses of misoprostol 800 mcg each (four tablets of 200 mcg per dose).
* Paracetamol, eight hourly, will be provided as analgesic or antipyretic.
* A specimen bottle to collect the POC if passed out.
* Two pairs of disposable gloves.
* Pre-filled histopathological examination form to be sent to the laboratory together with the products of conception
- **vaginal misoprostol** (DRUG) — All patients will receive three doses of vaginal misoprostol every four hours The first dose of misoprostol 800 mcg will be administrated at the hospital. Then the patient will be observed for 1 hour for any immediate adverse reaction Clear instructions about the method and timing of second dose will be given upon sending home.

Paracetamol, eight hourly, will be provided as analgesic or antipyretic

## Primary Outcomes

- **Completeness of abortion: expulsion of Products of conception (POC)x by visual inspection** _(time frame: 7 days)_

## Secondary Outcomes

- **Successful medical abortion: cervical os is closed with endometrial thickness of less than 15 mm** _(time frame: 7 days)_
- **Failure: endometrial thickness of more than 15 mm on day seven (from third dose of misoprostol) or developing of complications before day seven needing early surgical evacuation.** _(time frame: 7 days)_
- **Bleeding pattern following treatment** _(time frame: 7 days)_
- **Pain resulting from the procedure** _(time frame: 7 days)_
- **Additional uterotonic used** _(time frame: 7 days)_

## Locations (1)

- Ain shams university maternity hospital, Cairo, Egypt

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.ain shams university maternity hospital|cairo||egypt` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02686840.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02686840*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*