Misoprostol for Management of Women With an Incomplete Miscarriage

Miscarriage Clinical Trial

Official title:

Comparative Study Between Two Doses of Misoprostol in Women With Incomplete First-trimester Miscarriage After Misoprostol Treatment: A Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05088720
• Other study ID #: aswu/354/7/19
• 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

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.

Description:

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

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:

• 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

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Miscarriage

Intervention

Drug:
• misoprostol 800 µg
received misoprostol 800 µg (Misotac 200 µg tablets, SIGMA pharmaceutical) once dose sublingually
• misoprostol 400 µg
received misoprostol 400 µg (Misotac 200 µg tablets, SIGMA pharmaceutical) once dose sublingually

Locations

Country	Name	City	State
Egypt	Aswan University Hospital	Aswan

Sponsors (1)

Lead Sponsor	Collaborator
Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of patients with complete miscarriage at 1 week	The number of patients with complete miscarriage at 1 week	7 days