Sublingual Versus Vaginal Misoprostol In Medical Treatment of Second Trimestric Missed Miscarriage

Aswan University Hospital

Status: Unknown

Conditions: Miscarriage

Treatments: Drug: sublingual misoprostol; Drug: vaginal misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT05088707

aswu/354/3/18

Details and patient eligibility

About

The aim of this work is to compare the effectiveness of vaginal versus sub-lingual misoprostol for medical treatment of the second trimester missed miscarriage

Full description

In women with second trimester-missed miscarriage, sublingual misoprostol may be as vaginal misoprostol in the achievement of successful miscarriage so our aim was to compare the effectiveness of vaginal versus sub-lingual misoprostol for medical treatment of the second trimester missed miscarriage.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All women above 18 years of age
• between 13-26 weeks of gestation.
• Pregnancy is confirmed by a pregnancy test or ultrasound scan.
• missed abortion
• Normal general and gynecological examination.

Exclusion criteria

• Hemodynamically unstable.
• Suspected sepsis with temperature 38 °C.
• Concurrent medical illness e.g. hematological, cardiovascular, thromboembolism,
• respiratory illnesses, recent liver disease, or pruritus of pregnancy.
• Presence of intrauterine contraceptive device (IUCD).
• Suspect or proven ectopic pregnancy.
• -Failed medical or surgical evacuation before the presentation.
• Known allergy to misoprostol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

sublingual misoprostol

Experimental group

Description:

All patients will receive three doses of sublingual misoprostol every four hours. The first dose of misoprostol 800 mcg will be administrated at the hospital. Then the patient will be observed for 1 hour for any immediate adverse reaction Clear instructions about the method and timing of the second dose will be given upon sending home. Two doses of misoprostol 800 mcg each (four tablets of 200 mcg per dose). Paracetamol, eight hourly, will be provided as an analgesic or antipyretic. A specimen bottle to collect the POC if passed out. Two pairs of disposable gloves. Pre-filled histopathological examination form to be sent to the laboratory together with the products of conception

Treatment:

Drug: sublingual misoprostol

vaginal misoprostol

Active Comparator group

Description:

All patients will receive three doses of vaginal misoprostol every four hours The first dose of misoprostol 800 mcg will be administrated at the hospital. Then the patient will be observed for 1 hour for any immediate adverse reaction Clear instructions about the method and timing of the second dose will be given upon sending home. Paracetamol, eight hourly, will be provided as analgesic or antipyretic

Treatment:

Drug: vaginal misoprostol