Preterm LaborPhase 4NCT07865949
Oral Nifedipine vs Vaginal Progesterone for Prolonging Pregnancy in Preterm Labor
A Phase 4 study testing Nifedipine 20 Mg and Vaginal micronized progesterone in people with Preterm Labor, run by Medicare Hospital (Pvt) Limited at 1 site in Pakistan.
Trial summary
The purpose of this randomized clinical trial is to compare oral nifedipine and vaginal progesterone for prolonging pregnancy in women who develop preterm labor. Preterm labor can lead to early birth and related complications for newborns. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Preterm Labor
- What is being tested?
- Nifedipine 20 Mg and Vaginal micronized progesterone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2025to 30 Jan 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with singleton pregnancies (on antenatal scan)
- Presenting with preterm labor between 24 - 34 weeks of gestation
- Successful acute tocolysis for 48 hours
- and Received steroids
Who cannot join
- Multiple pregnancy
- Preterm premature rupture of membranes
- Congenital anomalies
- Cervical dilatation >3 cm (clinical examination)
- and who refuse to participate
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Medicare Hospital (Pvt) Limited
Multan, Punjab Province, 60000
About this study
Official title: Comparison of Oral Nifedipine Versus Vaginal Progesterone in Prolongation of Pregnancy With Preterm Labor
The purpose of this randomized clinical trial is to compare oral nifedipine and vaginal progesterone for prolonging pregnancy in women who develop preterm labor. Preterm labor can lead to early birth and related complications for newborns. The study will examine whether vaginal progesterone can prolong pregnancy for more than one week after treatment is started compared with oral nifedipine.
The main question this study aims to answer is:
Read more
- Is pregnancy prolonged for more than one week in a greater proportion of women receiving vaginal progesterone compared with women receiving oral nifedipine?
The study will include 84 women with singleton pregnancies between 24 and 34 weeks of gestation who have preterm labor, have responded successfully to initial treatment to stop contractions for 48 hours, and have received corticosteroids to help mature the baby's lungs.
Participants will be randomly assigned to one of two groups:
- Group A: Oral nifedipine, given initially at 20 mg followed by 10-20 mg three times daily, up to a maximum of 60 mg per day.
- Group B: Micronized progesterone 400 mg administered vaginally once daily.
Treatment will continue until 36 weeks and 6 days of pregnancy or until delivery. Participants will be followed weekly after discharge until delivery. The researchers will record the gestational age at delivery and whether pregnancy was prolonged by more than one week from the time of randomization.
- Conditions
- Preterm Labor
- Being tested
- Nifedipine 20 Mg, Vaginal micronized progesterone
- Keywords
- Preterm Labor, Preterm Birth, Pregnancy Prolongation, Nifedipine, Progesterone, Tocolysis, Preterm Delivery, Oral Nifedipine, Gestational Age, Vaginal Progesterone
- Medical subject headings
- Obstetric Labor, Premature, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nifedipine 20 MgDrug
After successful tocolysis oral nifedipine will be administered at an initial dose of 20 mg, followed by 20 mg three times daily, with a maximum daily dose of 60 mg. Treatment will continue until 36 weeks and 6 days of gestation or delivery.
Vaginal micronized progesteroneDrug
After successful tocolysis micronized progesterone 400 mg will be administered vaginally once daily. Treatment will continue until 36 weeks and 6 days of gestation or delivery.
| Study group | Role | What they receive |
|---|---|---|
| Oral Nifedipine | Active comparator | After successful acute tocolysis women in this arm will be given oral nifedipine Receives: Drug: Nifedipine 20 Mg |
| Vaginal Progesterone | Experimental | After successful tocolysis, women in this arm will get vaginal progesterone Receives: Drug: Vaginal micronized progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy prolongation
Pregnancy will be considered prolonged when the duration of pregnancy increases by more than 1 week from the day of randomization.
Measured: From the day of randomization until delivery or 36 weeks and 6 days of gestation, whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start1 Aug 2025
- Primary completion30 Jan 2026
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicare Hospital (Pvt) Limited
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sana Iqbal, Medicare Hospital (Pvt) Limited
- Investigators
- Shahid I Professor, FCPS, Study chair, Medicare Hospital (Pvt) Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07865949
- Sponsor's protocol ID
- U1111-1347-7628
- Status last verified
- Oct 2026
- First submitted
- 3 Oct 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Oral Nifedipine Versus Vaginal Progesterone in Prolongation of Pregnancy With Preterm Labor
- ClinicalTrials.gov ID
- NCT07865949
- Acronym / sponsor ID
- U1111-1347-7628
- Conditions
- Preterm Labor
- Keywords
- Preterm Labor, Preterm Birth, Pregnancy Prolongation, Nifedipine, Progesterone, Tocolysis, Preterm Delivery, Oral Nifedipine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Medicare Hospital (Pvt) LimitedUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 8 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this randomized clinical trial is to compare oral nifedipine and vaginal progesterone for prolonging pregnancy in women who develop preterm labor. Preterm labor can lead to early birth and related complications for newborns. The study will examine whether vaginal progesterone can prolong pregnancy for more than one week after treatment is started compared with oral nifedipine.
The main question this study aims to answer is:
- Is pregnancy prolonged for more than one week in a greater proportion of women receiving vaginal progesterone compared with women receiving oral nifedipine?
The study will include 84 women with singleton pregnancies between 24 and 34 weeks of gestation who have preterm labor, have responded successfully to initial treatment to stop contractions for 48 hours, and have received corticosteroids to help mature the baby's lungs.
Participants will be randomly assigned to one of two groups:
- Group A: Oral nifedipine, given initially at 20 mg followed by 10-20 mg three times daily, up to a maximum of 60 mg per day.
- Group B: Micronized progesterone 400 mg administered vaginally once daily.
Treatment will continue until 36 weeks and 6 days of pregnancy or until delivery. Participants will be followed weekly after discharge until delivery. The researchers will record the gestational age at delivery and whether pregnancy was prolonged by more than one week from the time of randomization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Nifedipine | Active comparator | Drug: Nifedipine 20 MgAfter successful acute tocolysis women in this arm will be given oral nifedipine |
| Vaginal Progesterone | Experimental | Drug: Vaginal micronized progesteroneAfter successful tocolysis, women in this arm will get vaginal progesterone |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women with singleton pregnancies (on antenatal scan)
- Presenting with preterm labor between 24 - 34 weeks of gestation
- Successful acute tocolysis for 48 hours
- and Received steroids
Key exclusion criteria (5 listed)
- Multiple pregnancy
- Preterm premature rupture of membranes
- Congenital anomalies
- Cervical dilatation >3 cm (clinical examination)
- and who refuse to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nifedipine 20 MgAfter successful tocolysis oral nifedipine will be administered at an initial dose of 20 mg, followed by 20 mg three times daily, with a maximum daily dose of 60 mg. Treatment will continue until 36 weeks and 6 days of gestation or delivery. | Drug | Oral Nifedipine |
| Vaginal micronized progesteroneAfter successful tocolysis micronized progesterone 400 mg will be administered vaginally once daily. Treatment will continue until 36 weeks and 6 days of gestation or delivery. | Drug | Vaginal Progesterone |
Primary outcome
Pregnancy prolongation
Time frame: From the day of randomization until delivery or 36 weeks and 6 days of gestation, whichever occurs first.
Pregnancy will be considered prolonged when the duration of pregnancy increases by more than 1 week from the day of randomization.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shahid I Professor, FCPS study chair
Medicare Hospital (Pvt) Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nifedipine 20 Mg and Vaginal micronized progesterone in people with Preterm Labor, run by Medicare Hospital (Pvt) Limited at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy prolongation (time frame: From the day of randomization until delivery or 36 weeks and 6 days of gestation, whichever occurs first.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.