Threatened Preterm Labour: Vaginal Progesterone Versus Ni... | NCT07649668

Studies
Threatened Preterm Labour: Vaginal Progesterone Versus Nifedipine

NCT07649668

Sponsor

Dr Mudassar Saeed Pansota

Status

Completed

Last Update Posted

Jun 16, 2026Actual

Enrollment

160Actual

Phase

Phase 4

Conditions

Preterm Labor

Interventions

Vaginal progesterone 200mg daily
Nifedipine 20 Mg

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 30, 2025Actual

Primary Completion Date

May 29, 2026Actual

Completion Date

May 29, 2026Actual

First Submitted Date

Jun 5, 2026

First Submission Date that Met QC Criteria

Jun 10, 2026

First Posted Date

Jun 16, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 10, 2026

Last Update Posted Date

Jun 16, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr Mudassar Saeed Pansota, Associate Professor, Shahida Islam Medical ComplexSponsor-Investigator

Lead Sponsor

Dr Mudassar Saeed PansotaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vaginal Progesterone	Experimental		Drug: Vaginal progesterone 200mg daily
Nifedipine	Placebo Comparator		Drug: Nifedipine 20 Mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Female

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Aqdas Aziz, MBBS	Hilal-e-Ahmar Hospital, Faisalabad	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hilal-e-ahmar Hospital		Faisalabad	Punjab Province	60000	Pakistan

Condition Browse Module

MeSH Terms

ID	Term
D007752	Obstetric Labor, Premature

Ancestor Terms

ID	Term
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009543	Nifedipine

Ancestor Terms

ID	Term
D004095	Dihydropyridines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided