Misoprostol for Management of Women With an Incomplete Miscarriage

NCT05088720 | Unknown DMC

• 1 other identifier: aswu/354/7/19
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Miscarriage

Outcome Measures

Primary Outcomes (1)

• The number of patients with complete miscarriage at 1 week

  The number of patients with complete miscarriage at 1 week

  7 days

Study Arms (2)

misoprostol 800 µg

EXPERIMENTAL

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

Drug: misoprostol 800 µg

misoprostol 400 µg

ACTIVE COMPARATOR

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

Drug: misoprostol 400 µg

Interventions

misoprostol 800 µg DRUG

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

misoprostol 800 µg

misoprostol 400 µg DRUG

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

Also known as: Active Comparator

misoprostol 400 µg

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: women with incomplete missed abortion
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (1)

Aswan University Hospital

Aswān, 81528, Egypt

Location

MeSH Terms

Conditions

Abortion, Spontaneous

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: a double-blind placebo-controlled randomized trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: A Professor

Model Details: a double-blind placebo-controlled randomized trial

Study Record Dates

• First Submitted: October 10, 2021
• First Posted: October 22, 2021
• Study Start: November 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: March 31, 2023
• Last Updated: October 22, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)