Threatened Preterm Labour: Vaginal Progesterone Versus Nifedipine

NCT07649668 | Completed Phase 4 DMC

• 1 other identifier: Hilal-e-Ahmar Hospital
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Preterm Labor

Keywords

Threatened preterm labour; vaginal progesterone; nifedipine

Outcome Measures

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

  48 hours

Study Arms (2)

Vaginal Progesterone

EXPERIMENTAL

Drug: Vaginal progesterone 200mg daily

Nifedipine

PLACEBO COMPARATOR

Drug: Nifedipine 20 Mg

Interventions

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).

Nifedipine

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)

Vaginal Progesterone

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr Mudassar Saeed Pansota: lead

Study Sites (1)

Hilal-e-ahmar Hospital

Faisalabad, Punjab Province, 60000, Pakistan

Location

MeSH Terms

Conditions

Obstetric Labor, Premature

Interventions

Nifedipine

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Aqdas Aziz, MBBS

  Hilal-e-Ahmar Hospital, Faisalabad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 16, 2026
• Study Start: November 30, 2025
• Primary Completion: May 29, 2026
• Study Completion: May 29, 2026
• Last Updated: June 16, 2026

Record last verified: 2026-06

Locations

PA (1)