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

Missed Abortion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02686840
• Other study ID #: ASUMH
• Status: Completed
• Phase: Phase 3
• First received: January 27, 2016
• Last updated: August 13, 2017
• Start date: January 2016
• Est. completion date: March 2017

Study information

• Verified date: August 2017
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abortion, Missed
• Abortion, Spontaneous
• Missed Abortion

Intervention

Drug:
• 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
• 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

Locations

Country	Name	City	State
Egypt	Ain shams university maternity hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completeness of abortion: expulsion of Products of conception (POC)x by visual inspection		7 days
Secondary	Successful medical abortion: cervical os is closed with endometrial thickness of less than 15 mm		7 days
Secondary	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.		7 days
Secondary	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	7 days
Secondary	Pain resulting from the procedure	this will be assessed by the doses of paracetamol given in mg	7 days
Secondary	Additional uterotonic used	additional misoprostol doses in mcg	7 days