PGE2 Followed by Oxytocin vs Oxytocin in Term PROM (POXY-PROM) (POXY-PROM)

February 18, 2026 updated by: National Hospital of Obstetrics and Gynecology

Comparison of the Effectiveness of Labor Induction Using Dinoprostone Followed by Oxytocin Versus Oxytocin Alone in Term Pregnancies With Premature Rupture of Membranes and an Unfavorable Cervix - A Randomized Clinical Trial

This study is being done to learn more about the best way to start labor for pregnant women whose water breaks at term before labor begins, a condition called term prelabor rupture of membranes (term PROM). When this happens and the cervix is not ready for labor, it is unclear which induction method works best and is safest for mother and baby.

The purpose of this study is to compare two common ways to induce labor in women with term PROM and an unfavorable cervix (Bishop score ≤ 6). One group will receive a vaginal dinoprostone insert (Propess) for 6 hours to soften the cervix, followed by oxytocin if labor does not start. The other group will receive immediate oxytocin through a vein.

Pregnant women aged 18 years or older with a single baby in head-down position at 37-42 weeks, whose water has broken and whose cervix is not yet favorable, may be able to join this study. All care will be provided at the National Hospital of Obstetrics and Gynecology in Hanoi, Vietnam, where both medicines are already used in routine practice.

The main outcome is how many women have a vaginal birth. The study will also look at how long it takes from induction to birth, complications for mothers and babies, and women's experiences of labor. The results may help doctors choose the safest and most effective way to induce labor for women with term PROM in the future.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Prelabor rupture of membranes at term (term PROM) occurs in approximately 8% of pregnancies and is associated with increased risks of maternal infection, neonatal morbidity, and cesarean delivery when labor does not begin promptly. International guidelines recommend active induction of labor for women with term PROM; however, the optimal induction strategy for women presenting with an unfavorable cervix (Bishop score ≤ 6) remains uncertain.

Oxytocin is widely used for induction of labor and is effective when the cervix is favorable, but its efficacy may be reduced in the presence of an unripe cervix. Prostaglandin E2 (dinoprostone) is commonly used for cervical ripening and may improve the likelihood of vaginal delivery when administered prior to oxytocin. Previous randomized trials comparing dinoprostone followed by oxytocin with oxytocin alone have suggested potential benefits, but the available evidence is limited by small sample sizes and inconsistent results. Additional high-quality randomized evidence is therefore required to guide clinical practice in this population.

This randomized controlled trial compares two induction strategies for women with term PROM and an unfavorable cervix: (1) cervical ripening using a 6-hour vaginal dinoprostone (Propess) insert followed by intravenous oxytocin if labor has not commenced, and (2) immediate induction with intravenous oxytocin alone. Both interventions are routinely used in clinical practice in Vietnam and are considered safe.

Participants are randomly assigned in a 1:1 ratio using a computer-generated randomization sequence with variable block sizes of 4 and 6, with allocation concealment ensured through centralized randomization. Randomization is performed after confirmation of eligibility and completion of the informed consent process. Participants remain in their assigned study arm throughout the trial, and no crossover between arms is permitted. All aspects of intrapartum care, including fetal heart rate monitoring, assessment of labor progress, and management of uterine tachysystole or other complications, are conducted according to standard institutional protocols.

The primary outcome of the study is vaginal delivery. Secondary outcomes are selected in accordance with the internationally developed core outcome set for trials on induction of labour and include key maternal, neonatal, and patient-reported outcomes. Maternal outcomes include mode of delivery, time from induction to delivery, need for oxytocin augmentation, uterine hyperstimulation, postpartum hemorrhage, maternal infection, admission to intensive care, hysterectomy, and maternal death. Neonatal outcomes include Apgar scores, admission to the neonatal intensive care unit, neonatal infection, hypoxic-ischemic encephalopathy or need for therapeutic hypothermia, and neonatal death. Patient-reported outcomes, including overall labor pain and maternal satisfaction with the birth process, are also assessed.

A total sample size of 450 participants has been calculated to provide adequate statistical power while accounting for potential attrition. The findings of this study are expected to clarify whether cervical ripening with dinoprostone prior to oxytocin induction improves clinically meaningful outcomes for women with term PROM and an unfavorable cervix, and may help inform future national and international guidelines on induction of labor.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
450

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Vietnam
    • Hanoi
      • Hanoi, Hanoi, Vietnam, 100000
        • Recruiting
        • National Hospital of Obstetrics and Gynecology
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Maternal age ≥ 18 years
  • Gestational age from 37 to 42 weeks, determined by last menstrual period or by a first- or second-trimester ultrasound
  • Live singleton fetus

  • Prelabor rupture of membranes (PROM) confirmed by at least one of the following:

    • Amniotic fluid visibly draining from the cervical os during sterile speculum examination
    • Pool of fluid in the posterior fornix
  • Cephalic presentation
  • Bishop score ≤ 6
  • No spontaneous uterine contractions
  • No contraindications for vaginal delivery

Exclusion Criteria:

  • Active labor
  • Previous uterine surgery (e.g., cesarean section)
  • Chorioamnionitis or non-reassuring fetal status
  • Major fetal anomalies
  • Contraindications to prostaglandin or vaginal delivery
  • Refusal to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Dinoprostone (Propess) + Oxytocin
Participants in this arm will receive a 10-mg vaginal dinoprostone insert (Propess) for cervical ripening. After 6 hours, if active labor has not begun or uterine contractions are inadequate, intravenous oxytocin will be started according to the hospital's standardized induction protocol. Continuous fetal monitoring and standardized management of uterine tachysystole will be applied. This approach reflects a sequential induction method commonly used for women with term PROM and an unfavorable cervix.
Drug: Sequential Induction: Dinoprostone Followed by Oxytocin
A sequential induction strategy in which a 10-mg vaginal dinoprostone insert (Propess) is placed for cervical ripening. After 6 hours, if active labor has not begun or uterine contractions are inadequate, intravenous oxytocin is initiated according to the hospital's standardized induction protocol. Continuous fetal monitoring is applied, and tachysystole is managed per institutional guidelines.
Other Names:
  • Dinoprostone (Propess)
Active Comparator: Immediate Oxytocin Induction
Participants in this arm will receive immediate induction of labor using intravenous oxytocin according to the hospital's standardized induction protocol. No cervical ripening agent will be used before starting oxytocin. Maternal and fetal status will be monitored throughout labor, and uterine tachysystole will be managed in line with institutional guidelines. This arm represents the comparator strategy of inducing labor directly with oxytocin in women with term PROM and an unfavorable cervix.
Drug: Immediate Oxytocin Induction
Intravenous oxytocin is used for immediate induction of labor in women with term prelabor rupture of membranes and an unfavorable cervix. Oxytocin is started according to the hospital's standardized induction protocol without prior use of cervical ripening agents. Maternal and fetal status are monitored throughout labor, and uterine tachysystole is managed according to institutional guidelines.
Other Names:
  • Oxytocin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Vaginal delivery
Time Frame: From induction until delivery, assessed up to 36 hours after randomization
Number of participants delivered vaginally
From induction until delivery, assessed up to 36 hours after randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mode of delivery
Time Frame: Within 24 hours from labor induction
Number of participants according to mode of delivery, categorized as vaginal delivery, operative vaginal delivery (forceps), or cesarean section
Within 24 hours from labor induction
Time from induction of labor to delivery
Time Frame: From induction until delivery, assessed up to 24 hours after induction
Duration from induction of labor to delivery (hours)
From induction until delivery, assessed up to 24 hours after induction
Oxytocin augmentation
Time Frame: From induction until delivery, assessed up to 24 hours after induction
Number of participants in the intervention group (Group I) who received intravenous oxytocin during the induction process
From induction until delivery, assessed up to 24 hours after induction
Uterine hyperstimulation
Time Frame: From induction until delivery, assessed up to 24 hours after induction
Number of participants who experienced uterine hyperstimulation, defined as more than 5 uterine contractions in 10 minutes over a minimal period of two consecutive 10-minute intervals, and/or a single uterine contraction lasting more than 3 minutes with fetal heart rate changes
From induction until delivery, assessed up to 24 hours after induction
Maternal satisfaction
Time Frame: Once between 90 minutes and 3 hours after delivery
Maternal satisfaction, assessed using a 5-point Likert scale, where 1 indicates very dissatisfied and 5 indicates very satisfied
Once between 90 minutes and 3 hours after delivery
Haemorrhage
Time Frame: Within 24 hours from delivery
Number of participants who experienced postpartum haemorrhage, defined as estimated blood loss greater than 500 mL after vaginal birth or greater than 1000 mL after caesarean birth within 24 hours after delivery
Within 24 hours from delivery
Uterine rupture
Time Frame: From randomization until maternal hospital discharge, assessed up to 28 days after randomization
Number of participants with uterine rupture
From randomization until maternal hospital discharge, assessed up to 28 days after randomization
Hysterectomy for any complications resulting from birth
Time Frame: From delivery until maternal hospital discharge, assessed up to 28 days after delivery
Number of participants who underwent hysterectomy for any complication resulting from childbirth
From delivery until maternal hospital discharge, assessed up to 28 days after delivery
Maternal infection
Time Frame: From induction until maternal hospital discharge, assessed up to 28 days after induction

Number of participants with maternal infection, defined as the presence of at least one of the following criterias:

Fever (defined as a temperature ≥38.0 degrees Celsius). Start of intravenous broad-spectrum antibiotics (with evidence of infection confirmed by clinical and subclinical presentation).

Endometritis, myometritis or urinary tract infection (proven positive vaginal discharge/urine culture).
From induction until maternal hospital discharge, assessed up to 28 days after induction
Damage to internal organs
Time Frame: From delivery until maternal hospital discharge, assessed up to 28 days after delivery
Number of participants with injury to internal organs, including intestines, bladder, or ureters, diagnosed clinically and/or confirmed intraoperatively during delivery or postpartum care.
From delivery until maternal hospital discharge, assessed up to 28 days after delivery
Intensive care admission
Time Frame: From randomization until maternal hospital discharge, assessed up to 28 days after randomization
Number of participants admitted to the intensive care unit
From randomization until maternal hospital discharge, assessed up to 28 days after randomization
Cardiorespiratory arrest
Time Frame: From randomization until maternal hospital discharge, assessed up to 28 days after randomization
Number of participants who experienced cardiorespiratory arrest
From randomization until maternal hospital discharge, assessed up to 28 days after randomization
Pulmonary embolus
Time Frame: From randomization until maternal hospital discharge, assessed up to 28 days after randomization
Number of participants diagnosed with pulmonary embolism
From randomization until maternal hospital discharge, assessed up to 28 days after randomization
Stroke
Time Frame: From randomization until maternal hospital discharge, assessed up to 28 days after randomization
Number of participants diagnosed with stroke
From randomization until maternal hospital discharge, assessed up to 28 days after randomization
Maternal death
Time Frame: From randomization until maternal hospital discharge, assessed up to 28 days after randomization
Number of participants who died from any cause between randomization and maternal hospital discharge
From randomization until maternal hospital discharge, assessed up to 28 days after randomization
Length of maternal hospital stay
Time Frame: From admission until maternal hospital discharge, assessed up to 28 days after admission
Duration of stay in hospital (days)
From admission until maternal hospital discharge, assessed up to 28 days after admission
Birth trauma
Time Frame: From delivery until neonatal hospital discharge, assessed up to 28 days after delivery
Number of neonates with birth trauma, defined as the presence of at least one birth-related traumatic injury, including bone fracture, traumatic pneumothorax, facial nerve palsy, brachial plexus injury, or other clinically diagnosed birth-related trauma, identified by clinical examination and/or imaging during the neonatal hospital stay
From delivery until neonatal hospital discharge, assessed up to 28 days after delivery
Hypoxic ischaemic encephalopathy or need for therapeutic hypothermia
Time Frame: From delivery until neonatal hospital discharge, assessed up to 28 days after delivery
Number of neonates with hypoxic ischemic encephalopathy or need for therapeutic hypothermia
From delivery until neonatal hospital discharge, assessed up to 28 days after delivery
Meconium aspiration syndrome
Time Frame: From delivery until neonatal hospital discharge, assessed up to 07 days after delivery

Number of neonates diagnosed with meconium aspiration syndrome, defined by the presence of:

Meconium-stained amniotic fluid Respiratory distress at birth or shortly after birth Characteristic radiographic features: The initial chest film may show streaky, linear densities -> the lungs typically appear hyper-inflated with flattening of the diaphragms.
From delivery until neonatal hospital discharge, assessed up to 07 days after delivery
Need for respiratory support
Time Frame: From delivery until neonatal hospital discharge, assessed up to 28 days after delivery
Number of neonates requiring respiratory support, defined as the use of one or more of the following interventions within the first 72 hours after birth: Endotracheal intubation; Continuous Positive Airway Pressure (CPAP); High-flow nasal cannula (HFNC); Use of respiratory support as part of ventilation or cardiopulmonary resuscitation.
From delivery until neonatal hospital discharge, assessed up to 28 days after delivery
Neonatal infection
Time Frame: From delivery until neonatal hospital discharge, assessed up to 28 days after delivery

Number of neonates diagnosed with neonatal infection, defined as meeting at least one of the following criteria:

Presence of a clinically ill neonate in whom systemic infection is suspected and confirmed by a positive blood culture, cerebrospinal fluid (CSF) culture, or catheterized/suprapubic urine culture; Or, in the absence of positive cultures, clinical evidence of cardiovascular collapse consistent with infection; Or radiographic evidence (e.g., chest X-ray) confirming infection.
From delivery until neonatal hospital discharge, assessed up to 28 days after delivery
Neonatal seizures
Time Frame: From delivery until neonatal hospital discharge, assessed up to 28 days after delivery
Number of neonates with neonatal seizures
From delivery until neonatal hospital discharge, assessed up to 28 days after delivery
Neonatal death
Time Frame: From delivery until neonatal hospital discharge, assessed up to 28 days after delivery
Number of neonates who died during the intrapartum period, neonatal period, or perinatal period
From delivery until neonatal hospital discharge, assessed up to 28 days after delivery
Admission to the neonatal unit
Time Frame: From delivery until neonatal admission, assessed up to 7 days after delivery
Number of neonates admitted to the neonatal unit
From delivery until neonatal admission, assessed up to 7 days after delivery

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Vaginal delivery within 12 hours
Time Frame: From induction until delivery, assessed up to 12 hours after induction
Number of participants delivered vaginally within 12 hours
From induction until delivery, assessed up to 12 hours after induction
Reaching active phase of labor
Time Frame: From induction until reaching active phase, assessed up to 12 hours after induction
Number of participants who developed regular uterine contractions accompanied by cervical dilation of ≥5 cm, as assessed by a qualified obstetric provider
From induction until reaching active phase, assessed up to 12 hours after induction
Time from induction to dinoprostone insert removal
Time Frame: From induction until dinoprostone vaginal insert removal, assessed up to 12 hours after induction
Duration from induction to dinoprostone vaginal insert removal (hours). Applicable to participants in the dinoprostone insert arm only
From induction until dinoprostone vaginal insert removal, assessed up to 12 hours after induction
Time from induction to active phase of labor
Time Frame: From induction until reaching active phase of labor, assessed up to 12 hours after induction
Duration from induction to active phase of labor (hours)
From induction until reaching active phase of labor, assessed up to 12 hours after induction
Time from membrane rupture to induction
Time Frame: From membrane rupture until initiation of labor induction, assessed up to 24 hours after membrane rupture
Duration from the first confirmed rupture of membranes (either by maternal report of clear fluid leakage or clinical diagnosis) to the initiation of labor induction (hours)
From membrane rupture until initiation of labor induction, assessed up to 24 hours after membrane rupture
Time from membrane rupture to delivery
Time Frame: From membrane rupture until delivery, assessed up to 36 hours after membrane rupture
Duration from the first confirmed rupture of membranes (either by maternal report of clear fluid leakage or clinical diagnosis) to delivery (hours).
From membrane rupture until delivery, assessed up to 36 hours after membrane rupture
Time from intrapartum antibiotic prophylaxis to delivery
Time Frame: From the first dose of intrapartum antibiotic prophylaxis until delivery
Time interval (in hours) from the first dose of intravenous intrapartum antibiotic prophylaxis to delivery
From the first dose of intrapartum antibiotic prophylaxis until delivery
Meconium-stained amniotic fluid
Time Frame: From membrane rupture until delivery, assessed up to 36 hours after membrane rupture
Number of participants with meconium-stained amniotic fluid, defined as the presence of meconium in the amniotic fluid, as documented by clinical staff during labor or at delivery
From membrane rupture until delivery, assessed up to 36 hours after membrane rupture
Use of tocolysis for excessive uterine activity
Time Frame: From induction until delivery, assessed up to 24 hours after induction
Number of participants who required tocolytic treatment due to excessive uterine activity during labor induction
From induction until delivery, assessed up to 24 hours after induction
Maternal side effects related to labor induction
Time Frame: From induction until delivery, assessed up to 24 hours after induction
Number of participants experiencing maternal side effects related to labor induction, including nausea, vomiting, diarrhea, or other gastrointestinal symptoms
From induction until delivery, assessed up to 24 hours after induction
Use of analgesia during labor
Time Frame: From induction until delivery, assessed up to 24 hours after induction
Number of participants who received any form of analgesia during labor, including epidural analgesia, systemic opioids (e.g., fentanyl), or other pharmacological pain relief methods
From induction until delivery, assessed up to 24 hours after induction
Postpartum blood transfusion
Time Frame: From delivery until maternal hospital discharge, assessed up to 28 days after delivery
Number of participants having maternal post-partum blood transfusion
From delivery until maternal hospital discharge, assessed up to 28 days after delivery
Uterine atony
Time Frame: From delivery until maternal hospital discharge, assessed up to 28 days after delivery
Number of participants with uterine atony requiring treatment with two or more uterotonic agents other than oxytocin and/or additional interventions, including manual uterine compression, compression sutures, uterine artery ligation, embolization, hypogastric artery ligation, or balloon tamponade
From delivery until maternal hospital discharge, assessed up to 28 days after delivery
Hysterectomy
Time Frame: From delivery until maternal hospital discharge, assessed up to 28 days after delivery
Number of participants who underwent hysterectomy for any postpartum complication
From delivery until maternal hospital discharge, assessed up to 28 days after delivery
Group B Streptococcus colonization
Time Frame: From diagnosis to delivery
Number of participants with Group B Streptococcus (GBS) colonization, defined as a positive screening test for Streptococcus agalactiae during the late third trimester
From diagnosis to delivery
Overall labor pain
Time Frame: Assessed once between 90 minutes and 3 hours after delivery
Maternal overall pain experienced during labor, assessed using a 0-10 Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable
Assessed once between 90 minutes and 3 hours after delivery
Composite maternal outcome
Time Frame: From randomization until maternal hospital discharge, assessed up to 28 days after randomization
Number of participants with at least one of the following maternal complications: chorioamnionitis, postpartum hemorrhage, intensive care unit admission, hysterectomy, uterine rupture, cervical tear, or maternal death
From randomization until maternal hospital discharge, assessed up to 28 days after randomization
Apgar score at 1 minute
Time Frame: Assessed at 1 minute after birth
Apgar score assessed at 1 minute after birth
Assessed at 1 minute after birth
Apgar score at 5-minute
Time Frame: Assessed at 5-minute after birth
Apgar score assessed at 5-minute after birth
Assessed at 5-minute after birth
Low Apgar score at 1 or 5-minute
Time Frame: Assessed at 1 and 5-minute after birth
Number of neonates with an Apgar score of 7 or less at 1 or 5-minute after birth
Assessed at 1 and 5-minute after birth
Admission to neonatal intensive care unit
Time Frame: From delivery until NICU admission, assessed up to 7 days after delivery
Number of neonates admitted to the Neonatal Intensive Care Unit (NICU)
From delivery until NICU admission, assessed up to 7 days after delivery
Reasons for NICU admission
Time Frame: From delivery until Neonatal Intensive Care Unit admission, assessed up to 28 days after delivery
Reason for Neonatal Intensive Care Unit admission such as: respiratory distress, hypoglycemia, seizures, etc..
From delivery until Neonatal Intensive Care Unit admission, assessed up to 28 days after delivery
Length of NICU stay
Time Frame: From admission to Neonatal Intensive Care Unit until neonatal discharge or hospital referral, assessed up to 28 days after Neonatal Intensive Care Unit admission
Duration from admission to Neonatal Intensive Care Unit to Neonatal Intensive Care Unit discharge or hospital referral
From admission to Neonatal Intensive Care Unit until neonatal discharge or hospital referral, assessed up to 28 days after Neonatal Intensive Care Unit admission
Neonatal hypoglycemia
Time Frame: From delivery until neonatal hospital discharge, assessed up to 28 days after delivery
Number of neonates with hypoglycemia
From delivery until neonatal hospital discharge, assessed up to 28 days after delivery
Neonatal jaundice and hyperbilirubinemia
Time Frame: From delivery until neonatal hospital discharge, assessed up to 28 days after delivery
Number of neonates diagnosed with jaundice and hyperbilirubinemia during the neonatal hospital stay
From delivery until neonatal hospital discharge, assessed up to 28 days after delivery
Intracranial hemorrhage
Time Frame: From delivery until neonatal hospital discharge, assessed up to 28 days after delivery.who received blood transfusion
Number of neonates diagnosed with intracranial hemorrhage, defined as any bleeding within the cranial vault confirmed by clinical assessment and/or imaging studies, including intraventricular hemorrhage, subdural hemorrhage, subarachnoid hemorrhage, or subgaleal hemorrhage
From delivery until neonatal hospital discharge, assessed up to 28 days after delivery.who received blood transfusion
Neonatal blood transfusion
Time Frame: From delivery until neonatal hospital discharge, assessed up to 28 days after delivery
Number of neonates who received blood transfusion during the neonatal hospital stay
From delivery until neonatal hospital discharge, assessed up to 28 days after delivery
Neonatal hospital referral
Time Frame: From delivery until neonatal hospital referral, assessed up to 28 days after delivery
Number of neonates referred to another hospital due to severe neonatal complications
From delivery until neonatal hospital referral, assessed up to 28 days after delivery
Composite neonatal outcome
Time Frame: From delivery until neonatal hospital discharge, assessed up to 28 days after delivery
Number of neonates experiencing at least one of the following events: low Apgar score, prematurity, neonatal intensive care unit admission, neonatal infection, neonatal seizures, respiratory distress syndrome, intraventricular hemorrhage, necrotizing enterocolitis, or perinatal death
From delivery until neonatal hospital discharge, assessed up to 28 days after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Hospital of Obstetrics and Gynecology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 10, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NHOG.2025.POXY-PROM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The investigators have not yet decided whether individual participant data will be shared. As the study has not yet been conducted, there is currently limited information regarding the effectiveness of the interventions and potential risks. The decision on data sharing will depend on future considerations, including institutional policies, ethical approvals, and the establishment of appropriate data governance and data sharing agreements to ensure participant confidentiality.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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