Utrogestan Versus Nifedipine as Tocolysis for Preterm Labor: a Randomised Controlled Trial (UTROGESTAN)

nor zila hassan malek

Status and phase: Unknown; Phase 2

Conditions: Preterm Labor

Treatments: Drug: Nifedipine; Drug: utrogestan

Study type: Interventional

Funder types: Other

Identifiers

NCT01985594

FF-2013-407

Details and patient eligibility

About

RESEARCH HYPOTHESIS

-Incidence of preterm delivery is lower in women treated with oral micronized progesterone (Utrogestan) as acute tocolysis agent compare to Nifedipine group with fewer maternal side effect

Enrollment: 32 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Singleton pregnancy women between 22 and 34 weeks of gestation who presented with threatened preterm labor.

Exclusion criteria

• Multiple pregnancies
• Women with Preterm Prelabour Rupture of Membrane
• Fetal death
• Women with bad obstetric history
• Women with history of cervical incompetence
• Contraindication to Nifedipine such as cardiovascular disease, hyperthyroidism, severe pre eclampsia or to Utrogestan
• Maternal or fetal indication for immediate delivery, such as fetal distress, bleeding placenta previa, abruption placenta
• Contraindication for tocolysis, for example severe pre eclampsia, intrauterine growth restriction, fetal anomaly, chorioamnionitis, significant antepartum haemorrhage
• Cervical dilatation of 3cm or more
• Patients with previous tocolytic treatment during this pregnancy
• Women who refuse to participate in this study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups, including a placebo group

Utrogestan

Active Comparator group

Description:

oral tablet Utrogestan 400mg daily for 2 days

Treatment:

Drug: utrogestan

Nifedipine

Placebo Comparator group

Description:

tablet Nifedipine 20 mg stat then 20 mg after 30 minutes then another 20 mg after 30 minutes followed by 10 mg three times daily for 2 days

Treatment:

Drug: Nifedipine