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Management of Women With an Incomplete Miscarriage

Misoprostol Versus Expectant Management in Women With Incomplete First-trimester Miscarriage After Misoprostol Treatment: A Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03148561
Enrollment
84
Registered
2017-05-11
Start date
2017-07-01
Completion date
2019-07-01
Last updated
2020-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Miscarriage

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.

Interventions

DRUGMisoprostol

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
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 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

Design outcomes

Primary

MeasureTime frame
The number of patients with complete miscarriage at 1 week.1 week

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026