Misoprostol for Management of Women With an Incomplete Miscarriage

Not Applicable

• Conditions: Miscarriage
• Interventions: Drug: misoprostol 800 µg; Drug: misoprostol 400 µg

• Registration Number: NCT05088720
• Lead Sponsor: Aswan University Hospital

Brief Summary

Miscarriage is defined as the spontaneous loss of a pregnancy before 24 weeks gestation, that is, before fetal viability. The clinical signs of miscarriage are usually vaginal bleeding associated with abdominal pain and cramping. The miscarriage is named 'complete' or 'incomplete' according to whether or not tissues are retained in the uterus. If a woman has minimal bleeding but her cervix is closed, this is known as a 'threatened miscarriage. However; if the pregnancy is still inside the uterus but the cervix is open, this is described as an 'inevitable miscarriage', which it will not usually be possible to save the fetus.

Detailed Description

the aim of the study is to evaluate 2 doses with misoprostol in Women With Incomplete First-trimester Miscarriage After Misoprostol Treatment

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-10-10
• Study First Submitted QC: 2021-10-10
• Last Update Submitted: 2021-10-10
• Study First Posted: 2021-10-22
• Last Update Posted: 2021-10-22
• Study Start: 2021-11-01
• Primary Completion: 2022-12-31
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Women with confirmed incomplete induced miscarriage, less than 12 weeks' gestation.
• No known allergy to misoprostol.
• Women who will be hemodynamically stable.
• Good access to emergency facilities

Exclusion Criteria

• Women with signs of severe infection ( fever > 38°)
• Women with severe vaginal bleeding
• Women are known to have allergies to prostaglandins
• Severe abdominal pain requiring immediate intervention

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
misoprostol 800 µg	misoprostol 800 µg	received misoprostol 800 µg (Misotac 200 µg tablets, SIGMA pharmaceutical) once dose sublingually
misoprostol 400 µg	misoprostol 400 µg	received misoprostol 400 µg (Misotac 200 µg tablets, SIGMA pharmaceutical) once dose sublingually

Primary Outcome Measures

Name	Time	Method
The number of patients with complete miscarriage at 1 week	7 days	The number of patients with complete miscarriage at 1 week

Trial Locations

Locations (1)

Aswan University Hospital; 🇪🇬 Aswan, Egypt