Isosorbide Mononitrate in Induction of Labour

Aljazeera Hospital

Status and phase: Unknown; Early Phase 1

Conditions: Labor Fast

Treatments: Drug: Isosorbide Mononitrate 40 MG; Drug: Misoprostol; Drug: Isosorbide Mononitrate 60 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT04482881

labour induction

Details and patient eligibility

About

Induction of labor is defined as the process of artificially initiating uterine contractions, prior to their spontaneous onset, with progressive effacement and dilatation of the cervix and ultimately, the delivery of the baby.

Full description

There are many indications for induction of labor in the obstetric practice, of which prolonged gestational age stands as the most common cause.

Enrollment: 130 estimated patients

Sex: Female

Ages: 18 to 42 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Single vertex presentation. 2. Gestational age > 37weeks calculated from last menstrual period or U/S scanning.

Exclusion criteria

1. Patients with rupture of membranes.
2. Previous uterine scar.
3. Fetal malpresentation.
4. Multiple pregnancies.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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130 participants in 3 patient groups

women receiving isosorbide mononitrates lower dose

Active Comparator group

Description:

women who will receive isosorbide mononitrates lower dose

Treatment:

Drug: Isosorbide Mononitrate 40 MG

women receiving isosorbide mononitrates higher dose

Active Comparator group

Description:

women who will receive isosorbide mononitrates higher dose

Treatment:

Drug: Isosorbide Mononitrate 60 MG

Women receiving misoprostol

Active Comparator group

Description:

Women who will receive misoprostol

Treatment:

Drug: Misoprostol