Preterm Labor With Intact MembranesPhase 4NCT07523295
Effect of Vaginal Progesterone Treatment on Pregnancy and Newborn Outcomes in Women With Preterm Labor
A Phase 4 study testing Nifedipine 20 Mg, Dexamethasone and Progesterone 200 mg vaginal capsules in people with Preterm Labor With Intact Membranes and Preterm Birth, run by Medicare Hospital (Pvt) Limited at 1 site in Pakistan.
Trial summary
Preterm labor, which occurs when labor starts before 37 weeks of pregnancy, is a major cause of illness and death in newborns. Babies born too early are at higher risk of breathing problems, low birth weight, infections, and other complications. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Preterm Labor With Intact Membranes, Preterm Birth
- What is being tested?
- Nifedipine 20 Mg, Dexamethasone and Progesterone 200 mg vaginal capsules
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 6 May 2025to 5 Nov 2025
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with singleton pregnancies (on antenatal scan)
- Presenting with pr-term labor
- Between 24 - 34 weeks of gestation
- Treated successfully with acute tocolysis for 48 hours and received steroids
Who cannot join
- Women with multiple pregnancy
- Preterm premature rupture of membranes
- Cervical dilatation >3 cm (clinical examination)
- Congenital fetal anomalies
- Refuse to participate in the study
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Medicare Hospital (Pvt) Limited
Multan, Punjab Province, 60000
About this study
Official title: Perinatal and Neonatal Outcomes of Vaginal Progesterone Supplementation in Women With Preterm Labor
Preterm labor, which occurs when labor starts before 37 weeks of pregnancy, is a major cause of illness and death in newborns. Babies born too early are at higher risk of breathing problems, low birth weight, infections, and other complications. Treatments that safely delay delivery can improve outcomes for both the mother and the baby.
The purpose of this clinical study is to determine whether vaginal progesterone treatment can improve pregnancy and newborn outcomes in women who present with preterm labor. The study will compare vaginal progesterone supplementation with conventional care after the initial treatment of preterm labor.
Read more
The main questions this study aims to answer are:
- Does vaginal progesterone increase the latency period (the time from treatment to delivery) in women with preterm labor?
- Does vaginal progesterone reduce the chances of preterm birth and low birth weight compared with conventional treatment?
This randomized controlled trial will be conducted in the Department of Obstetrics and Gynaecology at Medicare Hospital Multan. A total of 60 pregnant women with singleton pregnancies between 24 and 34 weeks of gestation who present with preterm labor will be enrolled in the study. All participants will first receive standard treatment for preterm labor, including medications to stop contractions (tocolysis with nifedipine for 48 hours) and steroid injections to help mature the baby's lungs.
Women whose contractions settle after the initial treatment will then be randomly assigned to one of two groups. One group will receive vaginal progesterone (400 mg daily), while the other group will receive conventional care, which includes counseling and routine pregnancy precautions without progesterone treatment.
Participants will continue their assigned management until 36 weeks and 6 days of pregnancy or until delivery occurs. After discharge from the hospital, all women will be followed every two weeks until delivery.
Researchers will record important pregnancy and newborn outcomes, including:
- Latency period (time from treatment to delivery)
- Preterm birth (delivery before 37 weeks of pregnancy)
- Birth weight of the newborn
By comparing these outcomes between the two groups, the study aims to determine whether vaginal progesterone can safely prolong pregnancy and improve neonatal outcomes in women with preterm labor. The results of this study may help guide future treatment strategies to reduce complications associated with premature birth.
- Conditions
- Preterm Labor With Intact Membranes, Preterm Birth
- Being tested
- Nifedipine 20 Mg, Dexamethasone, Progesterone 200 mg vaginal capsules, Counseling
- Keywords
- low birth weight, Preterm birth, Vaginal progesterone, Dexamethasone, nifedipine
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nifedipine 20 MgDrug
Oral Nifedipine 20 mg every 30-minutes for two doses, then 20 mg every 6-hours for 48-hours
DexamethasoneDrug
6 mg intramuscular every 12 hours for a total of four doses
Progesterone 200 mg vaginal capsulesDrug
two capsules (200 mg each) applied to the vagina daily till 36-weeks + 6 days or delivery
CounselingBehavioural
Standard counseling and precautionary advice provided after successful tocolysis
| Study group | Role | What they receive |
|---|---|---|
| Vaginal Progesterone | Experimental | Participants after successful tocolysis will receive vaginal progesterone Receives: Drug: Nifedipine 20 Mg; Drug: Dexamethasone; Drug: Progesterone 200 mg vaginal capsules |
| Conventional Care Group | Active comparator | Participants after successful tocolysis will receive counseling and precautionary advice Receives: Drug: Nifedipine 20 Mg; Drug: Dexamethasone; Behavioral: Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Latency Period
Time from randomization to delivery, measured in days, among women presenting with preterm labor after successful tocolysis.
Measured: From randomization until delivery (up to approximately 13 weeks, depending on gestational age at enrollment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start6 May 2025
- Primary completion5 Nov 2025
- Study completion5 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm Labor With Intact MembranesStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicare Hospital (Pvt) Limited
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Bushra Mukhtiar, Medicare Hospital (Pvt) Limited
- Investigators
- Muhammad S Akhtar, FRCOG, Study chair, Medicare Hospital (Pvt) Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07523295
- Sponsor's protocol ID
- U1111-1338-4965
- Status last verified
- Apr 2026
- First submitted
- 4 Apr 2026
- Last updated
- 13 Apr 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 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perinatal and Neonatal Outcomes of Vaginal Progesterone Supplementation in Women With Preterm Labor
- ClinicalTrials.gov ID
- NCT07523295
- Acronym / sponsor ID
- U1111-1338-4965
- Conditions
- Preterm Labor With Intact Membranes, Preterm Birth
- Keywords
- low birth weight, Preterm birth, Vaginal progesterone, Dexamethasone, nifedipine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medicare Hospital (Pvt) LimitedUniversity, hospital or other
- Study start
- 6 May 2025 (actual)
- Primary completion
- 5 Nov 2025 (actual)
- Study completion
- 5 Nov 2025 (actual)
- First posted
- 13 Apr 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.
Preterm labor, which occurs when labor starts before 37 weeks of pregnancy, is a major cause of illness and death in newborns. Babies born too early are at higher risk of breathing problems, low birth weight, infections, and other complications. Treatments that safely delay delivery can improve outcomes for both the mother and the baby.
The purpose of this clinical study is to determine whether vaginal progesterone treatment can improve pregnancy and newborn outcomes in women who present with preterm labor. The study will compare vaginal progesterone supplementation with conventional care after the initial treatment of preterm labor.
The main questions this study aims to answer are:
- Does vaginal progesterone increase the latency period (the time from treatment to delivery) in women with preterm labor?
- Does vaginal progesterone reduce the chances of preterm birth and low birth weight compared with conventional treatment?
This randomized controlled trial will be conducted in the Department of Obstetrics and Gynaecology at Medicare Hospital Multan. A total of 60 pregnant women with singleton pregnancies between 24 and 34 weeks of gestation who present with preterm labor will be enrolled in the study. All participants will first receive standard treatment for preterm labor, including medications to stop contractions (tocolysis with nifedipine for 48 hours) and steroid injections to help mature the baby's lungs.
Women whose contractions settle after the initial treatment will then be randomly assigned to one of two groups. One group will receive vaginal progesterone (400 mg daily), while the other group will receive conventional care, which includes counseling and routine pregnancy precautions without progesterone treatment.
Participants will continue their assigned management until 36 weeks and 6 days of pregnancy or until delivery occurs. After discharge from the hospital, all women will be followed every two weeks until delivery.
Researchers will record important pregnancy and newborn outcomes, including:
- Latency period (time from treatment to delivery)
- Preterm birth (delivery before 37 weeks of pregnancy)
- Birth weight of the newborn
By comparing these outcomes between the two groups, the study aims to determine whether vaginal progesterone can safely prolong pregnancy and improve neonatal outcomes in women with preterm labor. The results of this study may help guide future treatment strategies to reduce complications associated with premature birth.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaginal Progesterone | Experimental | Drug: Nifedipine 20 Mg, Drug: Dexamethasone, Drug: Progesterone 200 mg vaginal capsulesParticipants after successful tocolysis will receive vaginal progesterone |
| Conventional Care Group | Active comparator | Drug: Nifedipine 20 Mg, Drug: Dexamethasone, Behavioral: CounselingParticipants after successful tocolysis will receive counseling and precautionary advice |
Who may qualify
- Ages
- 18 to 45 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 pr-term labor
- Between 24 - 34 weeks of gestation
- Treated successfully with acute tocolysis for 48 hours and received steroids
Key exclusion criteria (5 listed)
- Women with multiple pregnancy
- Preterm premature rupture of membranes
- Cervical dilatation >3 cm (clinical examination)
- Congenital fetal anomalies
- Refuse to participate in the study
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 MgOral Nifedipine 20 mg every 30-minutes for two doses, then 20 mg every 6-hours for 48-hours | Drug | Conventional Care Group, Vaginal Progesterone |
| Dexamethasone6 mg intramuscular every 12 hours for a total of four doses | Drug | Conventional Care Group, Vaginal Progesterone |
| Progesterone 200 mg vaginal capsulestwo capsules (200 mg each) applied to the vagina daily till 36-weeks + 6 days or delivery | Drug | Vaginal Progesterone |
| CounselingStandard counseling and precautionary advice provided after successful tocolysis | Behavioural | Conventional Care Group |
Primary outcome
Latency Period
Time frame: From randomization until delivery (up to approximately 13 weeks, depending on gestational age at enrollment).
Time from randomization to delivery, measured in days, among women presenting with preterm labor after successful tocolysis.
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 13 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Preterm Labor With Intact Membranes
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A Combination of Antibiotics to Decrease Neonatal Morbidity and Mortality for Previable Threatened Labor
Previable Labour With Intact Membranes
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.
Muhammad S Akhtar, FRCOG 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, Dexamethasone and Progesterone 200 mg vaginal capsules in people with Preterm Labor With Intact Membranes and Preterm Birth, 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 13 Apr 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?
Latency Period (time frame: From randomization until delivery (up to approximately 13 weeks, depending on gestational age at enrollment).). 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 13 Apr 2026.