Misoprostol for Management of Women With an Incomplete Miscarriage

Aswan University Hospital

Status: Unknown

Conditions: Miscarriage

Treatments: Drug: misoprostol 400 µg; Drug: misoprostol 800 µg

Study type: Interventional

Funder types: Other

Identifiers

NCT05088720

aswu/354/7/19

Details and patient eligibility

About

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.

Full description

the aim of the study is to evaluate 2 doses with misoprostol in Women With Incomplete First-trimester Miscarriage After Misoprostol Treatment

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

200 participants in 2 patient groups

misoprostol 800 µg

Experimental group

Description:

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

Treatment:

Drug: misoprostol 800 µg

misoprostol 400 µg

Active Comparator group

Description:

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

Treatment:

Drug: misoprostol 400 µg