Management of Women With an Incomplete Miscarriage

• Sponsor: Assiut University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03148561
• Collaborator: (none)
• Enrollment: 84
• Location: 1
• Arms: 2
• Actual Duration (Months): 24
• Patients Per Site Per Month: 3.5

Study Details

Study Description

Brief Summary

Miscarriage is defined as the spontaneous loss of a pregnancy before 24 weeks' gestation, that is, before the fetal viability. The clinical signs of miscarriage are usually vaginal bleeding associated 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.

From many years, the surgical curettage ('evacuation of the uterus') was considered the 'gold standard management' for miscarriage to remove the retained placental tissue. It is quickly performed and removed almost all the retained products of conception. However, the routine surgical evacuation of the uterus associated with higher rate of morbidity and mortality and should be limited for special indications.

Many studies compared the effectiveness of medical treatment compared to surgery in management of incomplete abortion. There is only one study compared the curettage with expectant management in those women after medical therapy.However; none of them, looked at the effectiveness of the second chance of medical treatment in management of incomplete abortion in trial to avoid the surgical intervention after failure of previous medical treatment. So we think that the immediate evacuation using surgical intervention is truly unnecessary in most cases of failed medical abortion and the patients may get benefit from another trial of medical treatment.

Condition or Disease	Intervention/Treatment	Phase
Miscarriage	Drug: Misoprostol	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Misoprostol Versus Expectant Management in Women With Incomplete First-trimester Miscarriage After Misoprostol Treatment: A Randomized Clinical Trial
• Actual Study Start Date: Jul 1, 2017
• Actual Primary Completion Date: Jul 1, 2019
• Actual Study Completion Date: Jul 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: Misoprostol group The women received misoprostol 800 µg (Misotac 200 µg tablets, SIGMA pharmaceutical, Egypt) once dose placed in the posterior vaginal fornix	Drug: Misoprostol; received misoprostol 800 µg (Misotac 200 µg tablets, SIGMA pharmaceutical) once dose vaginally
No Intervention: Expectant group Women did not receive any medication.

Outcome Measures

Primary Outcome Measures

1. The number of patients with complete miscarriage at 1 week. [1 week]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Women with confirmed incomplete induced miscarriage, less than 12 weeks' gestation.

2. No known allergy to misoprostol.

3. Women who will be haemodynamically stable.

4. Good access to emergency facilities. Exclusion

5. Women with signs of severe infection ( fever > 38°) 2. Women with severe vaginal bleeding 3. Women known to have allergy to prostaglandins 4. Severe abdominal pain requiring immediate intervention

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Women Health Hospital - Assiut university	Assiut		Egypt	71111

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mohammed Khairy Ali, Lecturer, Assiut University
• ClinicalTrials.gov Identifier: NCT03148561
• Other Study ID Numbers: MWIE
• First Posted: May 11, 2017
• Last Update Posted: Jul 21, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Abortion, Spontaneous; Misoprostol

Study Results

No Results Posted as of Jul 21, 2020