Management of Women With an Incomplete Miscarriage

NCT ID: NCT03148561

Last Updated: 2020-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2019-07-01

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.

Conditions

Miscarriage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Misoprostol group

The women received misoprostol 800 µg (Misotac 200 µg tablets, SIGMA pharmaceutical, Egypt) once dose placed in the posterior vaginal fornix

Group Type: OTHER

Misoprostol

Intervention Type: DRUG

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

Expectant group

Women did not receive any medication.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Misoprostol

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

Intervention Type: DRUG

Eligibility Criteria

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

1. 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Khairy Ali

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Women Health Hospital - Assiut university

Asyut, , Egypt

Countries

Egypt

References

Ali MK, Emam SM, Abdel-Aleem MA, Sobh AMA. Misoprostol versus expectant management in women with incomplete first-trimester miscarriage after failed primary misoprostol treatment: A randomized clinical trial. Int J Gynaecol Obstet. 2021 Sep;154(3):558-564. doi: 10.1002/ijgo.13652. Epub 2021 Mar 24.

Reference Type: DERIVED

PMID: 33615468 (View on PubMed)

Other Identifiers

MWIE

Identifier Type: -

Identifier Source: org_study_id