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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaginal Progesterone | Experimental | Participants after successful tocolysis will receive vaginal progesterone |
|
| Conventional Care Group | Active Comparator | Participants after successful tocolysis will receive counseling and precautionary advice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nifedipine 20 Mg | Drug | Oral Nifedipine 20 mg every 30-minutes for two doses, then 20 mg every 6-hours for 48-hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Latency Period | Time from randomization to delivery, measured in days, among women presenting with preterm labor after successful tocolysis. | From randomization until delivery (up to approximately 13 weeks, depending on gestational age at enrollment). |
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| Measure | Description | Time Frame |
|---|---|---|
| Preterm Birth | Delivery occurring before 37 completed weeks of gestation, determined using the last menstrual period (LMP) method. | At delivery (up to approximately 13 weeks after randomization). |
| Low birth Weight |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Muhammad S Akhtar, FRCOG | Medicare Hospital (Pvt) Limited | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medicare Hospital (Pvt) Limited | Multan | Punjab Province | 60000 | Pakistan |
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| Dexamethasone | Drug | 6 mg intramuscular every 12 hours for a total of four doses |
|
| Progesterone 200 mg vaginal capsules | Drug | two capsules (200 mg each) applied to the vagina daily till 36-weeks + 6 days or delivery |
|
| Counseling | Behavioral | Standard counseling and precautionary advice provided after successful tocolysis |
|
Birth weight less than 2500 grams measured using a digital weighing scale at the time of delivery.
| At birth (up to approximately 13 weeks after randomization). |
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D009543 | Nifedipine |
| D003907 | Dexamethasone |
| D011374 | Progesterone |
| D003376 | Counseling |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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