Skip to main content
OpenTrials
Completed

NCT Number: NCT07649668

Threatened Preterm Labour: Vaginal Progesterone Versus Nifedipine

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Hilal-e-ahmar Hospital

Faisalabad, Punjab Province, 60000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vaginal progesterone 200mg daily

Drug

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)

Nifedipine 20 Mg

Drug

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).

Primary outcomes

  1. Percentage of efficacy

    Time frame: 48 hours

    Efficacy will be labeled in terms of delaying the delivery beyond 48 hours from the initiation of therapy or absence of preterm birth

Sponsors and collaborators

Lead sponsor

Dr Mudassar Saeed Pansota

Other

Registry information

Official study title

Efficacy of Vaginal Progesterone and Nifedipine in Inhibiting Threatened Preterm Labour

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 16, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.