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

NCT ID: NCT02686840

Last Updated: 2017-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-03-31

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.

Conditions

Missed Abortion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

sublingual misoprostol

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

Group Type: EXPERIMENTAL

sublingual misoprostol

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

vaginal misoprostol

Intervention Type: 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

Interventions

sublingual misoprostol

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

Intervention Type: DRUG

vaginal misoprostol

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

Intervention Type: DRUG

Other Intervention Names

Misotac; Misotac

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Abdel Shafy El Shahawy

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hassan A Bayoumy, MD

Role: STUDY_CHAIR

Ain Shams University

Locations

Ain shams university maternity hospital

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 30747547 (View on PubMed)

Other Identifiers

ASUMH

Identifier Type: -

Identifier Source: org_study_id