Comparative Study Between Combined Vaginal Misoprostol (comparative)

Cairo University (CU)

Status and phase: Unknown; Phase 1

Conditions: Missed Abortion

Treatments: Drug: Misoprostol and iso sorbide mononitrates

Study type: Interventional

Funder types: Other

Identifiers

NCT04981457

MS-196-2021

Details and patient eligibility

About

"Comparative study between Combined Vaginal Misoprostol with Isosorbide-5-Mononitrate

Full description

"Comparative study between Combined Vaginal Misoprostol with Isosorbide-5-Mononitrate versus Misoprostol Alone For Induction Of The first trimester Missed Abortion A Randomized Clinical Trial"

Enrollment: 60 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• • Maternal Age 18 - 35 years.
• Gestational age first trimester of pregnancy (between 5-13 weeks).
• Missed abortion confirmed by ultrasound.
• Singleton pregnancy.
• Normal uterus and cervix on clinical examination.
• Cervix is not dilated.
• No vaginal bleeding.

Exclusion Criteria:- Evidences suggesting start of spontaneous abortion and previous trial to induce abortion.

• Presence of uterine contraction or bleeding,
• Multi-fetal pregnancy.
• Suspicion of septic abortion.
• History of Previous cervical surgery or manipulation. Ex: cervical tear , cervical cauterization .
• Uterine anomaly.
• Presence of IUD( intrauterine device) in situ
• Underlying medical diseases.Ex:diabetes mellitus,hypertension
• History of allergy or adverse effects to vaginally administered medication e.g. isosorbide -5- mononitrate
• Those unwilling to participate in the trial
• Higher order cesarean section(more than three

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

patients who recieve misoprostol alone

Active Comparator group

Description:

Group A (n =30 ) will receive only vaginal Misoprostol 800mcg (4 tablets Cytotec 200mcg ) ) every 3 hours to a maximum of two doses or until reaching cervical ripening or uterine contractions or bleeding assessed by the same doctor who made evaluation at the beginning.

Treatment:

Drug: Misoprostol and iso sorbide mononitrates

patients who recieve misoprostol and iso sorbide mononitrate

Active Comparator group

Description:

Group B (n =30 ) will receive combined vaginal Misoprostol 800mcg (4 tablets Cytotec ) ) every 3 hours to a maximum of two doses or until reaching cervical ripening or start of uterine contractions or bleeding. with Isosorbide-5-mononitrate (20 mg). Effox 20 mg )once at the beginning with misoprostol until reaching cervical ripening or start of and uterine contractions assessed by the same doctor who made the evaluation at the beginning.

Treatment:

Drug: Misoprostol and iso sorbide mononitrates