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

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: Recruiting
• Conditions: Labor, Induced; Cervical Ripening; Premature Rupture of Fetal Membranes
• Intervention / Treatment: Drug: Sequential Induction: Dinoprostone Followed by Oxytocin; Drug: Immediate Oxytocin Induction

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: Interventional
• Enrollment (Estimated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Khuyen T.H Truong, MD; Phone Number: +84983851754; Email: khuyenth.hmu@gmail.com
• Study Contact Backup: Name: Anh T Ngo, MD, PhD; Phone Number: +84931686600; Email: dr.anhngo@nhog.vn

Study Locations

• Vietnam
  • Hanoi
    • Hanoi, Hanoi, Vietnam, 100000
      • Recruiting
      • National Hospital of Obstetrics and Gynecology
      • Contact: Ha T.T Nguyen, MD, PhD; Phone Number: +84965995599 +84989661093; Email: dr.hanguyen.nhog@gmail.com
      • Contact: Khuyen T.H Truong, MD; Phone Number: +84983851754; Email: truonghakhuyen@hmu.edu.vn

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Vaginal delivery	Number of participants delivered vaginally	From induction until delivery, assessed up to 36 hours after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mode of delivery	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	Duration from induction of labor to delivery (hours)	From induction until delivery, assessed up to 24 hours after induction
Oxytocin augmentation	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	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	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	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	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	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	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	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	Number of participants admitted to the intensive care unit	From randomization until maternal hospital discharge, assessed up to 28 days after randomization
Cardiorespiratory arrest	Number of participants who experienced cardiorespiratory arrest	From randomization until maternal hospital discharge, assessed up to 28 days after randomization
Pulmonary embolus	Number of participants diagnosed with pulmonary embolism	From randomization until maternal hospital discharge, assessed up to 28 days after randomization
Stroke	Number of participants diagnosed with stroke	From randomization until maternal hospital discharge, assessed up to 28 days after randomization
Maternal death	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	Duration of stay in hospital (days)	From admission until maternal hospital discharge, assessed up to 28 days after admission
Birth trauma	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	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	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	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	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	Number of neonates with neonatal seizures	From delivery until neonatal hospital discharge, assessed up to 28 days after delivery
Neonatal death	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	Number of neonates admitted to the neonatal unit	From delivery until neonatal admission, assessed up to 7 days after delivery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vaginal delivery within 12 hours	Number of participants delivered vaginally within 12 hours	From induction until delivery, assessed up to 12 hours after induction
Reaching active phase of labor	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	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	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	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	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 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	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	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	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	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	Number of participants having maternal post-partum blood transfusion	From delivery until maternal hospital discharge, assessed up to 28 days after delivery
Uterine atony	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	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	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	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	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	Apgar score assessed at 1 minute after birth	Assessed at 1 minute after birth
Apgar score at 5-minute	Apgar score assessed at 5-minute after birth	Assessed at 5-minute after birth
Low Apgar score at 1 or 5-minute	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	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	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	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	Number of neonates with hypoglycemia	From delivery until neonatal hospital discharge, assessed up to 28 days after delivery
Neonatal jaundice and hyperbilirubinemia	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	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	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	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	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

• Sponsor: National Hospital of Obstetrics and Gynecology

Publications and helpful links

General Publications

• Prelabor Rupture of Membranes: ACOG Practice Bulletin, Number 217. Obstet Gynecol. 2020 Mar;135(3):e80-e97. doi: 10.1097/AOG.0000000000003700.
• Inducing labour. London: National Institute for Health and Care Excellence (NICE); 2021 Nov 4. Available from http://www.ncbi.nlm.nih.gov/books/NBK579537/
• Kunt C, Kanat-Pektas M, Gungor AN, Kurt RK, Ozat M, Gulerman C, Gungor T, Mollamahmutoglu L. Randomized trial of vaginal prostaglandin E2 versus oxytocin for labor induction in term premature rupture of membranes. Taiwan J Obstet Gynecol. 2010 Mar;49(1):57-61. doi: 10.1016/S1028-4559(10)60010-1.
• Gungorduk K, Asicioglu O, Besimoglu B, Gungorduk OC, Yildirm G, Ark C, Sahbaz A. Labor induction in term premature rupture of membranes: comparison between oxytocin and dinoprostone followed 6 hours later by oxytocin. Am J Obstet Gynecol. 2012 Jan;206(1):60.e1-8. doi: 10.1016/j.ajog.2011.07.035. Epub 2011 Jul 30.
• Gulersen M, Zottola C, Li X, Krantz D, DiSturco M, Bornstein E. Chorioamnionitis after premature rupture of membranes in nulliparas undergoing labor induction: prostaglandin E2 vs. oxytocin. J Perinat Med. 2021 Jun 9;49(9):1058-1063. doi: 10.1515/jpm-2021-0094. Print 2021 Nov 25.
• Mackeen AD, Durie DE, Lin M, Huls CK, Qureshey E, Paglia MJ, Sun H, Sciscione A. Foley Plus Oxytocin Compared With Oxytocin for Induction After Membrane Rupture: A Randomized Controlled Trial. Obstet Gynecol. 2018 Jan;131(1):4-11. doi: 10.1097/AOG.0000000000002374.
• Borovac-Pinheiro A, Inversetti A, Di Simone N, Barnea ER; FIGO Childbirth and Postpartum Hemorrhage Committee. FIGO good practice recommendations for induced or spontaneous labor at term: Prep-for-Labor triage to minimize risks and maximize favorable outcomes. Int J Gynaecol Obstet. 2023 Oct;163 Suppl 2:51-56. doi: 10.1002/ijgo.15114.
• Middleton P, Shepherd E, Flenady V, McBain RD, Crowther CA. Planned early birth versus expectant management (waiting) for prelabour rupture of membranes at term (37 weeks or more). Cochrane Database Syst Rev. 2017 Jan 4;1(1):CD005302. doi: 10.1002/14651858.CD005302.pub3.
• Dos Santos F, Drymiotou S, Antequera Martin A, Mol BW, Gale C, Devane D, Van't Hooft J, Johnson MJ, Hogg M, Thangaratinam S. Development of a core outcome set for trials on induction of labour: an international multistakeholder Delphi study. BJOG. 2018 Dec;125(13):1673-1680. doi: 10.1111/1471-0528.15397. Epub 2018 Sep 10.

Helpful Links

• Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG). Term prelabour rupture of membranes (Term PROM). RANZCOG guideline [C-Obs 36]. Melbourne: RANZCOG; 2021

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: January 9, 2026
• First Submitted That Met QC Criteria: January 16, 2026
• First Posted (Actual): January 26, 2026

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Oxytocin; Vaginal Delivery; Cervical Ripening; Labor Induction; Dinoprostone; Premature Rupture of Fetal Membranes
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor Complications; Pregnancy Complications; Fetal Membranes, Premature Rupture; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Fatty Acids; Lipids; Biological Factors; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Autacoids; Inflammation Mediators; Pituitary Hormones, Posterior; Pituitary Hormones; Prostaglandins E; Oxytocin; Dinoprostone
• Other Study ID 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