Cervical Insufficiency, Pregnancy, High-Risk, Preterm Labour
Conditions
Keywords
Interventions, Population, Study design, Clinical focus
Brief summary
Preterm labour is a major cause of neonatal morbidity and mortality worldwide. Progesterone supplementation is known to help reduce the risk of preterm birth in high-risk women. This randomized controlled trial compared the effectiveness of intramuscular progesterone and rectal progesterone in preventing preterm labour among pregnant women who had undergone cervical cerclage. The study aimed to determine which route of progesterone administration provides better pregnancy prolongation and improved neonatal outcomes.
Detailed description
Background: Preterm labour remains one of the leading causes of perinatal mortality and long-term neonatal complications. Cervical insufficiency, often managed by cervical cerclage, is a recognized risk factor for preterm birth. Progesterone supplementation helps maintain uterine quiescence and cervical integrity, but the optimal route of administration after cerclage is not well established. Objective: To compare the efficacy of intramuscular progesterone versus rectal progesterone in preventing preterm labour among women who underwent cervical cerclage. Methods: This single-centre, randomized controlled trial was conducted in the Department of Obstetrics & Gynecology, Bahawal Victoria Hospital, Bahawalpur, Pakistan. Eligible women with singleton pregnancies who had undergone cervical cerclage were randomly assigned to receive either weekly intramuscular progesterone (250 mg) or daily rectal progesterone suppositories (400 mg) from 16 to 36 weeks of gestation. The primary outcome was the incidence of preterm labour before 37 weeks. Secondary outcomes included gestational age at delivery, neonatal birth weight, NICU admission, and maternal side effects. Significance: This study provides evidence on the comparative effectiveness of two commonly used routes of progesterone administration in women with cerclage, aiming to identify the safer and more convenient regimen for prolonging pregnancy and improving neonatal outcomes.
Interventions
Hydroxyprogesterone caproate 250 mg administered intramuscularly once weekly from 16 to 36 weeks of gestation following cervical cerclage. Used to maintain uterine quiescence and prevent preterm labour.
DRUGRectal Progesterone
Micronized progesterone 400 mg suppository administered rectally once daily from 16 to 36 weeks of gestation following cervical cerclage. Intended to provide sustained progesterone support and prevent preterm labour.
Sponsors
Hina Mukhtar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
Pregnant women aged 18-45 years Singleton pregnancy Gestational age between 16 and 24 weeks at enrollment Diagnosed with cervical insufficiency and scheduled for or recently undergone cervical cerclage Willing to receive progesterone therapy and provide written informed consent
Exclusion criteria
Multiple pregnancy Known fetal anomalies Severe maternal comorbidities (e.g., hypertension, diabetes, cardiac disease) History of allergy or hypersensitivity to progesterone or related compounds Contraindications to progesterone use Women who declined to participate or were non-compliant with follow-upInclusion Criteria: \-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of Preterm Birth (<37 Weeks) | 16-36 weeks until delivery |
Secondary
| Measure | Time frame |
|---|---|
| Gestational Age at Delivery | At delivery |
| Neonatal Birth Weight | At birth |
| Apgar Scores at 1 and 5 Minutes | Immediately post-delivery |
| NICU Admission Rate | Within 24 hours of birth |
| Maternal Adverse Effects | During treatment period (16-36 weeks) |
Countries
Pakistan
Outcome results
None listed