Preterm Labor
Conditions
Keywords
Preterm Labor, Preterm Birth, Pregnancy Prolongation, Nifedipine, Progesterone, Tocolysis, Preterm Delivery, Oral Nifedipine, Gestational Age, Vaginal Progesterone
Brief summary
The purpose of this randomized clinical trial is to compare oral nifedipine and vaginal progesterone for prolonging pregnancy in women who develop preterm labor. Preterm labor can lead to early birth and related complications for newborns. The study will examine whether vaginal progesterone can prolong pregnancy for more than one week after treatment is started compared with oral nifedipine. The main question this study aims to answer is: \- Is pregnancy prolonged for more than one week in a greater proportion of women receiving vaginal progesterone compared with women receiving oral nifedipine? The study will include 84 women with singleton pregnancies between 24 and 34 weeks of gestation who have preterm labor, have responded successfully to initial treatment to stop contractions for 48 hours, and have received corticosteroids to help mature the baby's lungs. Participants will be randomly assigned to one of two groups: * Group A: Oral nifedipine, given initially at 20 mg followed by 10-20 mg three times daily, up to a maximum of 60 mg per day. * Group B: Micronized progesterone 400 mg administered vaginally once daily. Treatment will continue until 36 weeks and 6 days of pregnancy or until delivery. Participants will be followed weekly after discharge until delivery. The researchers will record the gestational age at delivery and whether pregnancy was prolonged by more than one week from the time of randomization.
Interventions
After successful tocolysis micronized progesterone 400 mg will be administered vaginally once daily. Treatment will continue until 36 weeks and 6 days of gestation or delivery.
DRUGNifedipine 20 Mg
After successful tocolysis oral nifedipine will be administered at an initial dose of 20 mg, followed by 20 mg three times daily, with a maximum daily dose of 60 mg. Treatment will continue until 36 weeks and 6 days of gestation or delivery.
Sponsors
Medicare Hospital (Pvt) Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Women with singleton pregnancies (on antenatal scan) * Presenting with preterm labor between 24 - 34 weeks of gestation * Successful acute tocolysis for 48 hours * and Received steroids
Exclusion criteria
* Multiple pregnancy * Preterm premature rupture of membranes * Congenital anomalies * Cervical dilatation \>3 cm (clinical examination) * and who refuse to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy prolongation | From the day of randomization until delivery or 36 weeks and 6 days of gestation, whichever occurs first. | Pregnancy will be considered prolonged when the duration of pregnancy increases by more than 1 week from the day of randomization. |
Countries
Pakistan
Contacts
STUDY_CHAIRShahid I Professor, FCPS
Medicare Hospital (Pvt) Limited
Outcome results
None listed