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CompletedNCT07649668Updated Jun 16, 2026

Threatened Preterm Labour: Vaginal Progesterone Versus Nifedipine

A Phase 4 interventional study of Vaginal progesterone 200mg daily and Nifedipine 20 Mg in Preterm Labor, sponsored by Dr Mudassar Saeed Pansota. Completed at 1 site in Pakistan. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-06-16.

Sponsored by Dr Mudassar Saeed Pansota · Phase 4, Interventional, and Prevention

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Nov 2025, registered Jun 2026).
Phase
Phase 4
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • Preterm Labor

Keywords

  • Threatened preterm labour
  • vaginal progesterone
  • nifedipine
03

In context

Obstetric Labor, Premature

255 studies on the registry are indexed under Obstetric Labor, Premature; 38 are open to participants now.

This study's enrollment of 160 is above the median of 110 across 155 interventional studies indexed under Obstetric Labor, Premature.

Browse Obstetric Labor, Premature studies →

Lead sponsor

Dr Mudassar Saeed Pansota is the lead sponsor of 7 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
160 participants (actual)

Study arms

  • Experimental
    Vaginal Progesterone

    Drug: Vaginal progesterone 200mg daily

  • Placebo comparator
    Nifedipine

    Drug: Nifedipine 20 Mg

Interventions

  • DrugVaginal 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)

  • DrugNifedipine 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).

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 48 hours

07

Study locations

1 site
  • Hilal-e-ahmar Hospital
    Faisalabad, Punjab Province 60000, Pakistan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07649668
Lead sponsor
Dr Mudassar Saeed Pansota
Responsible party
Dr Mudassar Saeed Pansota (Associate Professor, Shahida Islam Medical Complex) — Sponsor-investigator
First posted
Jun 16, 2026
Start date
Nov 30, 2025
Primary completion
May 29, 2026
Completion
May 29, 2026
Last update
Jun 16, 2026

Study contacts

Aqdas Aziz, MBBS
principal investigator · Hilal-e-Ahmar Hospital, Faisalabad

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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