Sublingual Misoprostol In Medical Treatment of First Trimester Missed Miscarriage

Miscarriage Clinical Trial

Official title:

Sublingual Misoprostol 400 mcg and 800 mcg In Medical Treatment of First Trimester Missed Miscarriage: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05103098
• Other study ID #: aswu/354/9/19
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: March 31, 2023

Study information

• Verified date: October 2021
• Source: Aswan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this work is to compare the effectiveness of sublingual misoprostol 400 mcg versus 800 mcg for medical treatment of the first trimester missed miscarriage.

Description:

the study will be made on female patients with the first trimester missed abortion confirmed by ultrasound. Participants will be divided into 2 groups one group (A) will receive sublingual Misoprostol 400 mcg and the other group(B) will receive sublingual Misoprostol 800 mcg every 4 hours in both groups up to 3 doses the aim of the study is to compare the efficacy of sublingual Misoprostol in complete termination of the first trimester missed abortion and which route is the best will less side effects.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: March 31, 2023
• Est. primary completion date: December 31, 2022
• 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.

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 the presentation.

• Known allergy to misoprostol.

Related Conditions & MeSH terms

• Abortion, Missed
• Abortion, Spontaneous
• Miscarriage

Intervention

Drug:
• misoprostol 400 mcg
All patients will receive three doses of sublingual misoprostol every four hours The first dose of misoprostol 400 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 the second dose will be given upon sending home. Two doses of misoprostol 400 mcg each (four tablets of 200 mcg per dose). Paracetamol, eight hourly, will be provided as an 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
• misoprostol 800 mcg
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 the 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 an 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

Locations

Country	Name	City	State
Egypt	Aswan University Hospital	Aswan

Sponsors (1)

Lead Sponsor	Collaborator
hany farouk

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completeness of abortion	Number of Participants with expulsion of Products of conception by visual inspection	7 days
Secondary	Successful medical abortion	Number of Participants with cervical os is closed with endometrial thickness of less than 15 mm	7 days
Secondary	amount of calculated blood loss following treatment	amount of calculated blood loss	7 days