Vaginal Misoprostol In Medical Treatment of First Trimester Missed Miscarriage

Miscarriage Clinical Trial

Official title:

Vaginal Misoprostol 600 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: NCT05094375
• Other study ID #: aswu/354/10/19
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: June 30, 2023

Study information

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

Clinical Trial Summary

Efficacy of vaginal misoprostol 600 Mg versus 800 Mg in termination of the first trimester missed abortion were assist

Description:

In women with first trimetric-missed miscarriage, vaginal misoprostol in the achievement of successful miscarriage so our aim was to compare the effectiveness of vaginal misoprostol 600 Mg versus 800 Mg for medical treatment of the first trimester missed miscarriage.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: June 30, 2023
• Est. primary completion date: March 31, 2023
• 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 , 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:
• Vaginal Misoprostol 600 mcg
All patients will receive three doses of vaginal misoprostol every four hours. The first dose of misoprostol 600 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 600 mcg each (3 tablets of 200 mcg per dose). Paracetamol, eight hourlies, 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 800 mcg
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. Two doses of misoprostol 800 mcg each (four tablets of 200 mcg per dose). Paracetamol, eight hourlies, 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

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	expulsion of Products of conception by visual inspection	7 days
Secondary	Successful medical abortion	cervical os is closed with endometrial thickness of less than 15 mm	14 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	14 days