ClinicalTrials.gg
CompletedNCT02686840Updated Aug 16, 2017

Sublingual Versus Vaginal Misoprostol In Medical Treatment of First Trimestric Missed Miscarriage

A Phase 3 interventional study of sublingual misoprostol and vaginal misoprostol in Missed Abortion, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2017-08-16.

Sponsored by Ain Shams University · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 12 studies in Abortion, Missed with a site in Egypt — none open to participants now, none under way, none of them phase 3. Abortion, Missed · Egypt.

Enrollment
4th of 11
200 · median 140
Started
2016
the only one that year
Phase 3
2 of 12
none open now
Registered
2nd of 12
by date
Lead sponsor
2 of 12
Ain Shams University

Among the 12 studies in Abortion, Missed with a site in Egypt, this one is the 4th largest by enrollment of the 11 interventional ones, is the only one that started in 2016, is one of 2 in phase 3, and was the 2nd registered.

By phase

12 studies; the count open now beside each. This study's row is marked.

No phase3 · 0 open
Phase 23 · 0 open
Phase 3this study2 · 0 open
Phase 42 · 0 open
Observational1 · 0 open
Phase 11 · 0 open

By the year they started

First in 2015; this study’s year is marked. 1 started in 2016.

Size and results

Median enrollment 140 across the 11 interventional studies, 320 across the 1 observational. Of the 5 that completed or were terminated, 0 (0%) have results posted.

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Download CSVWith an account: the 12 studies in Abortion, Missed with a site in Egypt as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Missed Abortion

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04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 device (IUCD).
  • Suspect or proven ectopic pregnancy.
  • Failed medical or surgical evacuation before presentation.
  • Known allergy to misoprostol.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
200 participants (actual)

Study arms

  • Experimental
    sublingual misoprostol

    Group A (100 patients): will be treated with sublingual misoprostol

    Drug: sublingual misoprostol

  • Active comparator
    vaginal misoprostol

    Group B (100 patients): will be treated with vaginal misoprostol

    Drug: vaginal misoprostol

Interventions

  • 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

    Also known as: Misotac

  • 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

    Also known as: Misotac

06

What researchers measure

Primary outcomes

  1. Completeness of abortion: expulsion of Products of conception (POC)x by visual inspection

    Time frame: 7 days

Secondary outcomes

  1. Successful medical abortion: cervical os is closed with endometrial thickness of less than 15 mm

    Time frame: 7 days

  2. 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

  3. Bleeding pattern following treatment

    This will be assessed by hemoglobin(g/dl) and haematocrit level after the treatment , if the patients required blood transfusion and number of units transfused and number of days of bleeding

    Time frame: 7 days

  4. Pain resulting from the procedure

    this will be assessed by the doses of paracetamol given in mg

    Time frame: 7 days

  5. Additional uterotonic used

    additional misoprostol doses in mcg

    Time frame: 7 days

07

Study locations

1 site
  • Ain shams university maternity hospital
    Cairo, 25187, Egypt
08

References and documents

Publications

  • Abdelshafy A, Awwad H, Abo-Gamra A, Alanwar A, Elkotb AM, Shahin M, Abd El-Razek M, Abbas AM. Sublingual vs vaginal misoprostol for completion of first trimester missed abortion: a randomised controlled trial. Eur J Contracept Reprod Health Care. 2019 Apr;24(2):134-139. doi: 10.1080/13625187.2019.1569224. Epub 2019 Feb 12. PubMed 30747547 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2016 to primary completion in Jan 2017, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 27, 2016
First posted
Feb 22, 2016
StartActual
Jan 2016
Primary completionActual
Jan 2017
CompletionActual
Mar 2017
Last update
Aug 16, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 16, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02686840
Responsible party
Ahmed Abdel Shafy El Shahawy (Lecturer, Ain Shams University) — Principal investigator
First posted
Feb 22, 2016
Start date
Jan 2016
Primary completion
Jan 2017
Completion
Mar 2017
Last update
Aug 16, 2017

Study contacts

Hassan A Bayoumy, MD
study chair · Ain Shams University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Misoprostol

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