Threatened Preterm Labour: Vaginal Progesterone Versus Nifedipine

Efficacy of Vaginal Progesterone and Nifedipine in Inhibiting Threatened Preterm Labour

So, a number of studies have been conducted worldwide to find a suitable agent for arresting threatened preterm labor. The current study is planned to examine the effectiveness of nifedipine and progesterone in the treatment of threatened preterm labor (TPL). The result of this study will be used to recommend the best treatment modality in our population to reduce the risk of preterm labor

Study Overview

• Status: Completed
• Conditions: Preterm Labor
• Intervention / Treatment: Drug: Vaginal progesterone 200mg daily; Drug: Nifedipine 20 Mg

Detailed Description

Preterm birth is defined as any birth before 37 completed weeks of gestation, or fewer than 259 days of gestation. It is estimated that annually, 13 million preterm infants are born. The worldwide rates of preterm birth vary with an estimated prevalence of 5-25%. Approximately 60% of preterm infants are born in south Asia and sub-Saharan Africa.

Progesterone and nifedipine were tested as tocolytic medications in women who were at risk of preterm birth to see whether they had any influence on efficacy, success, and the effects on the mother and foetus. Nifedipine is a drug which was reported for stopping uterine contractions in preterm labour. It is calcium channel blockers have some qualities that make them a better choice as compared to others. They decrease calcium entry through cell membranes, so controlling muscle contractility in various tissues like uterus. However; its use for maintenance tocolysis has yielded conflicting results.

Various interventions have been attempted to reduce the risk of preterm birth in women at increased risk, including progesterone, cervical cerclage, and cervical pessary. Progesterone plays a role in the maintenance of pregnancy by suppression of the calcium-calmodulin-myosin light chain kinase system. Additionally, progesterone has recognized anti-inflammatory properties, raising a possible link between inflammatory processes, alterations in progesterone receptor expression and the onset of preterm labor.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 4

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Faisalabad, Punjab Province, Pakistan, 60000
      • Hilal-e-ahmar Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All the females aged 18-35 year
• Singleton pregnancy
• With gestational age of 24 weeks to 36 weeks
• With presentation of the threatened preterm labor

Exclusion Criteria:

• Pregnant women with presentation cervical dilation (>3 cm),
• Patients with known contraindications to receiving either vaginal progesterone or oral nifedipine
• Patients with co morbidities such as GDP, gestational hypertension, preeclampsia
• Multiple pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vaginal Progesterone	Drug: Vaginal progesterone 200mg daily; In Group B, participants will be instructed to use vaginal micronized progesterone tablets at a dosage of 200mg once daily or until reaching 37 weeks of gestational age or until cervical dilation exceeded 4cm (for a duration of 48 hours)
Placebo Comparator: Nifedipine	Drug: Nifedipine 20 Mg; In Group A, participants will receive oral nifedipine at a dose of 20mg every 30 minutes for three doses initially, followed by long-acting nifedipine SR 20mg every 12 hours until reaching 37 weeks of gestational age or until cervical dilation exceeded 4cm (for a duration of 48 hours).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of efficacy	Efficacy will be labeled in terms of delaying the delivery beyond 48 hours from the initiation of therapy or absence of preterm birth	48 hours

Collaborators and Investigators

• Sponsor: Dr Mudassar Saeed Pansota
• Investigators: Principal Investigator: Aqdas Aziz, MBBS, Hilal-e-Ahmar Hospital, Faisalabad

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2025
• Primary Completion (Actual): May 29, 2026
• Study Completion (Actual): May 29, 2026

Study Registration Dates

• First Submitted: June 5, 2026
• First Submitted That Met QC Criteria: June 10, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: nifedipine; vaginal progesterone; Threatened preterm labour
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor Complications; Pregnancy Complications; Obstetric Labor, Premature; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dihydropyridines; Nifedipine
• Other Study ID Numbers: Hilal-e-Ahmar Hospital

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No