Back to results

Misoprostol for Management of Women With an Incomplete Miscarriage

Primary Purpose

Miscarriage

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

misoprostol 800 µg

misoprostol 400 µg

About this trial

This is an interventional treatment trial for Miscarriage

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Aswan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

misoprostol 800 µg

misoprostol 400 µg

Arm Description

received misoprostol 800 µg (Misotac 200 µg tablets, SIGMA pharmaceutical) once dose sublingually

received misoprostol 400 µg (Misotac 200 µg tablets, SIGMA pharmaceutical) once dose sublingually

Outcomes

Primary Outcome Measures

The number of patients with complete miscarriage at 1 week

Secondary Outcome Measures

Full Information

NCT ID

NCT05088720

First Posted

October 10, 2021

Last Updated

October 10, 2021

Sponsor

Aswan University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05088720

Brief Title

Misoprostol for Management of Women With an Incomplete Miscarriage

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Unknown status

Study Start Date

November 1, 2021 (Anticipated)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

March 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Aswan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Miscarriage

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

a double-blind placebo-controlled randomized trial

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

a double-blind placebo-controlled randomized trial

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

misoprostol 800 µg

Arm Type

Experimental

Arm Description

received misoprostol 800 µg (Misotac 200 µg tablets, SIGMA pharmaceutical) once dose sublingually

Arm Title

misoprostol 400 µg

Arm Type

Active Comparator

Arm Description

received misoprostol 400 µg (Misotac 200 µg tablets, SIGMA pharmaceutical) once dose sublingually

Intervention Type

Drug

Intervention Name(s)

misoprostol 800 µg

Intervention Description

received misoprostol 800 µg (Misotac 200 µg tablets, SIGMA pharmaceutical) once dose sublingually

Intervention Type

Drug

Intervention Name(s)

misoprostol 400 µg

Other Intervention Name(s)

Active Comparator

Intervention Description

received misoprostol 400 µg (Misotac 200 µg tablets, SIGMA pharmaceutical) once dose sublingually

Primary Outcome Measure Information:

Title

The number of patients with complete miscarriage at 1 week

Description

The number of patients with complete miscarriage at 1 week

Time Frame

7 days

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

women with incomplete missed abortion

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Aswan University Hospital

City

Aswan

ZIP/Postal Code

81528

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Misoprostol for Management of Women With an Incomplete Miscarriage

We'll reach out to this number within 24 hrs