Rupture of Membranes Prior to Onset of LaborPhase 4PROMabNCT07563504
PROMab Trial: Ampicillin With or Without Gentamicin for Term Prelabour Rupture of Membranes
A Phase 4 study testing Ampicillin and Ampicillin + gentamicin in people with Rupture of Membranes Prior to Onset of Labor, run by Sarawak General Hospital at 3 sites in Malaysia.
Trial summary
The goal of this clinical trial is to learn whether adding gentamicin to standard ampicillin prophylaxis can better prevent clinical chorioamnionitis and other maternal and neonatal infectious complications in pregnant women aged 18 years or older with singleton, cephalic, term pregnancies and confirmed prelabour… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Rupture of Membranes Prior to Onset of Labor
- What is being tested?
- Ampicillin and Ampicillin + gentamicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 3 sitesMalaysia
- Study dates
- 1 Jul 2026to 31 Mar 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Singleton pregnancy
- Cephalic (vertex) presentation
- Term gestation of 37+0 weeks or more based on obstetric dating
- Confirmed prelabour rupture of membranes
- Duration of prelabour rupture of membranes 12 hours or less at the time of enrolment
Show all 11Show fewer
- Unknown or negative Group B Streptococcus status in the current pregnancy
- Clear amniotic fluid at presentation
- Afebrile with no clinical signs of intra-amniotic infection at admission
- Able to provide written informed consent
- Planned delivery at a participating study hospital
Who cannot join
- Preterm prelabour rupture of membranes before 37+0 weeks
- Fever of 38.0°C or higher, maternal tachycardia, uterine tenderness, purulent discharge, or other clinical suspicion of infection at admission
- Antibiotics already initiated in the current episode of care for any reason
- Receipt of systemic antibiotics in the past 7 days
- Meconium-stained liquor at presentation
- Contraindication to vaginal delivery, including malpresentation, major placenta praevia, maternal refusal of trial of labour after caesarean, or known absolute indication for elective lower segment caesarean section
Show all 15Show fewer
- Known Group B Streptococcus colonisation in the current pregnancy, including positive rectovaginal swab or bacteriuria
- Abnormal cardiotocography on admission requiring expedited delivery
- Allergy or contraindication to penicillin or aminoglycosides
- Renal impairment defined as creatinine clearance less than 30 mL/min
- Known renal disease
- Known ototoxicity risk or vestibular/cochlear disorders
- Unknown timing of prelabour rupture of membranes
- Multiple gestation
- Major fetal anomaly
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia3 sites
Sarawak General Hospital
Kuching, Sarawak, 93586
Jagdeesh Kaur, Medical Degree, +6 0122129958, jagdeesh_kaur@hotmail.com
Yan Hian Voon, Medical Degree, +6 0162317072, vhaxyn@gmail.com
Miri Hospital
Miri, Sarawak, 98000
Shan Pau Foong, Medical Degree, +6 0189071927, mushroomatwork@gmail.com
Sarikei Hospital
Sarikei, Sarawak, 96100
Cheng Ming Chai, Medical Degree, +6 0168709882, mingcheng.cmc@gmail.com
About this study
Official title: Term Prelabour Rupture of Membranes Antibiotic Prophylaxis (PROMab) Trial
The goal of this clinical trial is to learn whether adding gentamicin to standard ampicillin prophylaxis can better prevent clinical chorioamnionitis and other maternal and neonatal infectious complications in pregnant women aged 18 years or older with singleton, cephalic, term pregnancies and confirmed prelabour rupture of membranes. The main questions it aims to answer are:
Does ampicillin plus gentamicin reduce the incidence of clinical chorioamnionitis compared with ampicillin alone? Does ampicillin plus gentamicin improve maternal infectious outcomes and neonatal infection-related outcomes compared with ampicillin alone?
Read more
Researchers will compare ampicillin alone with ampicillin plus gentamicin to see whether broader antibiotic coverage reduces maternal and neonatal infectious morbidity.
Participants will:
- undergo screening and eligibility assessment
- provide written informed consent before randomisation
- be randomly assigned to receive either intravenous ampicillin alone or intravenous ampicillin plus gentamicin
- start study antibiotics at 12 hours after membrane rupture and continue treatment until delivery
- undergo routine maternal and fetal monitoring during labour and delivery have maternal and neonatal outcomes assessed during hospital stay and up to 42 days postpartum, including telephone follow-up at Day 14 and Day 42
- optionally consent to placental tissue collection for microbiological culture at delivery
- Being tested
- Ampicillin, Ampicillin + gentamicin
- Keywords
- Term PROM (Prelabour Rupture of Membranes), Intrapartum Antibiotic Prophylaxis, Ampicillin, Gentamicin, Clinical Chorioamnionitis, Maternal Infection, Neonatal Sepsis, Randomized Controlled Trial
- Medical subject headings
- Fetal Membranes, Premature Rupture, Neonatal Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmpicillinDrug
Intravenous ampicillin 2 g stat, followed by 1 g every 4 hours, initiated at 12 hours after prelabour rupture of membranes and continued until delivery.
Ampicillin + gentamicinDrug
Intravenous ampicillin 2 g stat, followed by intravenous ampicillin 1 g every 4 hours, plus intravenous gentamicin 5 mg/kg once daily. Study antibiotics will be initiated at 12 hours after prelabour rupture of membranes and continued until delivery. Gentamicin will only be administered to participants with baseline creatinine clearance of 30 mL/min or higher.
| Study group | Role | What they receive |
|---|---|---|
| Ampicillin Alone | Active comparator | Participants randomized to this arm will receive intravenous ampicillin 2 g stat, followed by intravenous ampicillin 1 g every 4 hours. Study antibiotics will be initiated at 12 hours after prelabour rupture of membranes and continued until delivery. If clinical chorioamnionitis develops, study prophylaxis will be discontinued and therapeutic antibiotics will be started according to local hospital protocol. Receives: Drug: Ampicillin |
| Ampicillin Plus Gentamicin | Experimental | Participants randomized to this arm will receive intravenous ampicillin 2 g stat, followed by intravenous ampicillin 1 g every 4 hours, plus intravenous gentamicin 5 mg/kg once daily. Study antibiotics will be initiated at 12 hours after prelabour rupture of membranes and continued until delivery. Gentamicin will only be administered to participants with baseline creatinine clearance of 30 mL/min or higher. If clinical chorioamnionitis develops, study prophylaxis will be discontinued and therapeutic antibiotics will be started according to local hospital protocol Receives: Drug: Ampicillin + gentamicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Chorioamnionitis
Incidence of clinical chorioamnionitis, defined as maternal temperature ≥39.0°C once, or maternal temperature 38.0-38.9°C plus at least one of the following: leukocytosis >15,000/mm³, purulent cervical or vaginal discharge, fetal tachycardia (baseline fetal heart rate >160 bpm for ≥10 minutes), or malodorous liquor.
Measured: From admission (diagnosis of PROM) until delivery (72 hours)
Secondary outcomes (15)
Intrapartum Maternal Fever
Incidence of intrapartum maternal fever, defined as axillary temperature ≥38.0°C on a single reading, or ≥37.5°C on two readings at least 1 hour apart during labour.
Measured: From admission (diagnosis of PROM) until delivery (72 hours)
Postpartum Fever During Index Admission
Incidence of postpartum fever, defined as axillary temperature ≥38.0°C recorded at any time after delivery until discharge during the index hospital admission.
Measured: From admission (diagnosis of PROM) until delivery 7 days postpartum
Early Postpartum Endometritis During Index Admission
Incidence of early postpartum endometritis diagnosed during the index hospital admission, defined as axillary temperature ≥38.0°C in the absence of an alternative identifiable cause and at least one associated clinical feature, including uterine tenderness, purulent or foul-smelling lochia, maternal tachycardia, or lower abdominal or uterine pain.
Measured: From admission (diagnosis of PROM) until delivery 7 days postpartum
Peripartum Infection During Index Admission
Incidence of peripartum infection, defined as the occurrence of clinical chorioamnionitis and/or early postpartum endometritis during the same hospital admission.
Measured: From admission (diagnosis of PROM) until delivery 7 days postpartum
Postpartum Antibiotic Treatment Exceeding 24 Hours
Incidence of systemic antibiotic therapy continued for more than 24 hours after delivery during the index hospital admission for suspected or confirmed infection, excluding routine single-dose perioperative prophylaxis for caesarean section.
Measured: From admission (diagnosis of PROM) until delivery 7 days postpartum
Puerperal Endometritis After Discharge
Incidence of puerperal endometritis diagnosed after hospital discharge and up to 42 days postpartum, based on clinical documentation and/or requirement for antibiotic treatment for endometritis.
Measured: From discharge until 42 days postpartum.
Wound Infection
Incidence of wound infection involving the caesarean section wound and/or perineal wound or episiotomy within 42 days postpartum, as evidenced by clinical diagnosis and/or treatment such as antibiotics, wound drainage, opening, or debridement.
Measured: From delivery until 42 days postpartum.
Infection-related Hospitalisation Longer Than 5 Days or Readmission for Infection
Incidence of infection-related hospitalisation longer than 5 days during the index admission and/or hospital readmission within 42 days postpartum with a primary diagnosis of infection and/or requiring systemic antibiotic therapy
Measured: From delivery until 42 days postpartum.
Culture-proven Early-onset Neonatal Sepsis
Incidence of culture-proven early-onset neonatal sepsis, defined as isolation of a pathogenic organism from blood and/or cerebrospinal fluid culture, with clinical features consistent with infection.
Measured: Within the first 72 hours of life
Neonatal Sepsis Evaluation
Incidence of neonatal sepsis evaluation, defined as performance of a neonatal septic work-up including one or more of the following: blood culture, full blood count, or other investigations performed as part of routine neonatal sepsis assessment.
Measured: From birth till 7 days of life
NICU Admission
Incidence of admission to the neonatal intensive care unit at any time during the neonatal hospital stay, for any indication.
Measured: From birth till 7 days of life
Composite Neonatal Adverse Outcome
Incidence of a composite neonatal adverse outcome defined as the occurrence of one or more of the following: requirement for ventilator support, tachypnoea with or without oxygen supplementation persisting beyond 6 hours of life, temperature instability requiring clinical intervention, or requirement for second-line antibiotics.
Measured: From birth till 7 days of life
Presumed Early-onset Neonatal Sepsis
Incidence of presumed early-onset neonatal sepsis, defined as culture-negative infants who receive at least 5 days of intravenous antibiotics based on clinical assessment, with or without supportive laboratory findings, as determined by the neonatal team.
Measured: From birth till 7 days of life.
Infection-related Neonatal Hospitalisation Longer Than 5 Days or Readmission
Incidence of neonatal hospitalisation longer than 5 days primarily attributed to suspected or confirmed infection and/or readmission within 42 days of life with a primary diagnosis of infection and/or requiring intravenous antibiotic therapy.
Measured: From birth until 42 days of life.
Placental Chorioamniotic Tissue Culture
Placental chorioamniotic tissue culture results obtained at delivery and categorized into predefined microbiological groups, including Enterobacteriaceae, Group B Streptococcus, anaerobes, Enterococcus faecalis, and negative cultures.
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Rupture of Membranes Prior to Onset of 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
- Model description
- Participants with term prelabour rupture of membranes will be randomized in a 1:1 ratio to one of two parallel groups: intravenous ampicillin alone or intravenous ampicillin plus gentamicin. Study antibiotics will be initiated at 12 hours after membrane rupture and continued until delivery.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sarawak General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jagdeesh Kaur, Sarawak General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07563504
- Sponsor's protocol ID
- PROMab-2026-01
- Acronym
- PROMab
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because there is currently no formal data-sharing plan or repository arrangement for this investigator-initiated study.
Publications
Rutanen EM, Karkkainen TH, Lehtovirta J, Uotila JT, Hinkula MK, Hartikainen AL. Evaluation of a rapid strip test for insulin-like growth factor binding protein-1 in the diagnosis of ruptured fetal membranes. Clin Chim Acta. 1996 Sep 30;253(1-2):91-101. doi: 10.1016/0009-8981(96)80001-e.
PubMed 8879841Abu Shqara R, Bussidan S, Glikman D, Rechnitzer H, Lowenstein L, Frank Wolf M. Clinical implications of uterine cultures obtained during urgent caesarean section. Aust N Z J Obstet Gynaecol. 2023 Jun;63(3):344-351. doi: 10.1111/ajo.13630. Epub 2022 Dec 4.
PubMed 36464667Montelongo EM, Blue NR, Lee RH. Placenta Accreta in a Woman with Escherichia coli Chorioamnionitis with Intact Membranes. Case Rep Obstet Gynecol. 2015;2015:121864. doi: 10.1155/2015/121864. Epub 2015 Dec 27.
PubMed 26819787Solomon S, Akeju O, Odumade OA, Ambachew R, Gebreyohannes Z, Van Wickle K, Abayneh M, Metaferia G, Carvalho MJ, Thomson K, Sands K, Walsh TR, Milton R, Goddard FGB, Bekele D, Chan GJ. Prevalence and risk factors for antimicrobial resistance among newborns with gram-negative sepsis. PLoS One. 2021 Aug 3;16(8):e0255410. doi: 10.1371/journal.pone.0255410. eCollection 2021.
PubMed 34343185World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.
PubMed 24141714Santschi EM, Papich MG. Pharmacokinetics of gentamicin in mares in late pregnancy and early lactation. J Vet Pharmacol Ther. 2000 Dec;23(6):359-63. doi: 10.1046/j.1365-2885.2000.00298.x.
PubMed 11168913Gribomont AC, Stragier A. [Idiopathic epimacular membrane and vitreo-macular traction syndrome: vitrectomy functional results]. Bull Soc Belge Ophtalmol. 1996;262:123-6. French.
PubMed 9376915Senat MV, Schmitz T, Bouchghoul H, Diguisto C, Girault A, Paysant S, Sibiude J, Lassel L, Sentilhes L. Term prelabor rupture of membranes: guidelines for clinical practice from the French College of Gynaecologists and Obstetricians (CNGOF). J Matern Fetal Neonatal Med. 2022 Aug;35(16):3105-3109. doi: 10.1080/14767058.2020.1810230. Epub 2020 Aug 27.
PubMed 32847438Cararach V, Botet F, Sentis J, Almirall R, Perez-Picanol E. Administration of antibiotics to patients with rupture of membranes at term: a prospective, randomized, multicentric study. Collaborative Group on PROM. Acta Obstet Gynecol Scand. 1998 Mar;77(3):298-302.
PubMed 9580172Hannah ME, Ohlsson A, Farine D, Hewson SA, Hodnett ED, Myhr TL, Wang EE, Weston JA, Willan AR. Induction of labor compared with expectant management for prelabor rupture of the membranes at term. TERMPROM Study Group. N Engl J Med. 1996 Apr 18;334(16):1005-10. doi: 10.1056/NEJM199604183341601.
PubMed 8598837Inducing labour. London: National Institute for Health and Care Excellence (NICE); 2021 Nov 4. Available from http://www.ncbi.nlm.nih.gov/books/NBK579537/
PubMed 35438865Committee Opinion No. 712: Intrapartum Management of Intraamniotic Infection. Obstet Gynecol. 2017 Aug;130(2):e95-e101. doi: 10.1097/AOG.0000000000002236.
PubMed 28742677Abu Shqara R, Glikman D, Goldinfeld G, Braude O, Assy S, Hassan D, Sgayer I, Ganem N, Shasha-Lavsky H, Yefet E, Matanis M, Lowenstein L, Frank Wolf M. Ampicillin and gentamicin prophylaxis is superior to ampicillin alone in patients with prelabor rupture of membranes at term: the results of a randomized clinical trial. Am J Obstet Gynecol. 2025 Oct;233(4):321.e1-321.e10. doi: 10.1016/j.ajog.2025.03.011. Epub 2025 Mar 12.
PubMed 40086563
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Term Prelabour Rupture of Membranes Antibiotic Prophylaxis (PROMab) Trial
- ClinicalTrials.gov ID
- NCT07563504
- Acronym / sponsor ID
- PROMab / PROMab-2026-01
- Keywords
- Term PROM (Prelabour Rupture of Membranes), Intrapartum Antibiotic Prophylaxis, Ampicillin, Gentamicin, Clinical Chorioamnionitis, Maternal Infection, Neonatal Sepsis, Randomized Controlled Trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Sarawak General HospitalUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 4 May 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 goal of this clinical trial is to learn whether adding gentamicin to standard ampicillin prophylaxis can better prevent clinical chorioamnionitis and other maternal and neonatal infectious complications in pregnant women aged 18 years or older with singleton, cephalic, term pregnancies and confirmed prelabour rupture of membranes. The main questions it aims to answer are:
Does ampicillin plus gentamicin reduce the incidence of clinical chorioamnionitis compared with ampicillin alone? Does ampicillin plus gentamicin improve maternal infectious outcomes and neonatal infection-related outcomes compared with ampicillin alone?
Researchers will compare ampicillin alone with ampicillin plus gentamicin to see whether broader antibiotic coverage reduces maternal and neonatal infectious morbidity.
Participants will:
- undergo screening and eligibility assessment
- provide written informed consent before randomisation
- be randomly assigned to receive either intravenous ampicillin alone or intravenous ampicillin plus gentamicin
- start study antibiotics at 12 hours after membrane rupture and continue treatment until delivery
- undergo routine maternal and fetal monitoring during labour and delivery have maternal and neonatal outcomes assessed during hospital stay and up to 42 days postpartum, including telephone follow-up at Day 14 and Day 42
- optionally consent to placental tissue collection for microbiological culture at delivery
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants with term prelabour rupture of membranes will be randomized in a 1:1 ratio to one of two parallel groups: intravenous ampicillin alone or intravenous ampicillin plus gentamicin. Study antibiotics will be initiated at 12 hours after membrane rupture and continued until delivery.
| Arm | Type | Receives |
|---|---|---|
| Ampicillin Alone | Active comparator | Drug: AmpicillinParticipants randomized to this arm will receive intravenous ampicillin 2 g stat, followed by intravenous ampicillin 1 g every 4 hours. Study antibiotics will be initiated at 12 hours after prelabour rupture of membranes and continued until delivery. If clinical chorioamnionitis develops, study prophylaxis will be discontinued and therapeutic antibiotics will be started according to local hospital protocol. |
| Ampicillin Plus Gentamicin | Experimental | Drug: Ampicillin + gentamicinParticipants randomized to this arm will receive intravenous ampicillin 2 g stat, followed by intravenous ampicillin 1 g every 4 hours, plus intravenous gentamicin 5 mg/kg once daily. Study antibiotics will be initiated at 12 hours after prelabour rupture of membranes and continued until delivery. Gentamicin will only be administered to participants with baseline creatinine clearance of 30 mL/min or higher. If clinical chorioamnionitis develops, study prophylaxis will be discontinued and therapeutic antibiotics will be started according to local hospital protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age 18 years or older
- Singleton pregnancy
- Cephalic (vertex) presentation
- Term gestation of 37+0 weeks or more based on obstetric dating
- Confirmed prelabour rupture of membranes
Key exclusion criteria (15 listed)
- Preterm prelabour rupture of membranes before 37+0 weeks
- Fever of 38.0°C or higher, maternal tachycardia, uterine tenderness, purulent discharge, or other clinical suspicion of infection at admission
- Antibiotics already initiated in the current episode of care for any reason
- Receipt of systemic antibiotics in the past 7 days
- Meconium-stained liquor at presentation
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 |
|---|---|---|
| AmpicillinIntravenous ampicillin 2 g stat, followed by 1 g every 4 hours, initiated at 12 hours after prelabour rupture of membranes and continued until delivery. | Drug | Ampicillin Alone |
| Ampicillin + gentamicinIntravenous ampicillin 2 g stat, followed by intravenous ampicillin 1 g every 4 hours, plus intravenous gentamicin 5 mg/kg once daily. Study antibiotics will be initiated at 12 hours after prelabour rupture of membranes and continued until delivery. Gentamicin will only be administered to participants with baseline creatinine clearance of 30 mL/min or higher. | Drug | Ampicillin Plus Gentamicin |
Primary outcome
Clinical Chorioamnionitis
Time frame: From admission (diagnosis of PROM) until delivery (72 hours)
Incidence of clinical chorioamnionitis, defined as maternal temperature ≥39.0°C once, or maternal temperature 38.0-38.9°C plus at least one of the following: leukocytosis >15,000/mm³, purulent cervical or vaginal discharge, fetal tachycardia (baseline fetal heart rate >160 bpm for ≥10 minutes), or malodorous liquor.
15 secondary outcomes
Intrapartum Maternal Fever
Time frame: From admission (diagnosis of PROM) until delivery (72 hours)
Postpartum Fever During Index Admission
Time frame: From admission (diagnosis of PROM) until delivery 7 days postpartum
Early Postpartum Endometritis During Index Admission
Time frame: From admission (diagnosis of PROM) until delivery 7 days postpartum
Peripartum Infection During Index Admission
Time frame: From admission (diagnosis of PROM) until delivery 7 days postpartum
Postpartum Antibiotic Treatment Exceeding 24 Hours
Time frame: From admission (diagnosis of PROM) until delivery 7 days postpartum
Puerperal Endometritis After Discharge
Time frame: From discharge until 42 days postpartum.
Wound Infection
Time frame: From delivery until 42 days postpartum.
Infection-related Hospitalisation Longer Than 5 Days or Readmission for Infection
Time frame: From delivery until 42 days postpartum.
Culture-proven Early-onset Neonatal Sepsis
Time frame: Within the first 72 hours of life
Neonatal Sepsis Evaluation
Time frame: From birth till 7 days of life
NICU Admission
Time frame: From birth till 7 days of life
Composite Neonatal Adverse Outcome
Time frame: From birth till 7 days of life
Presumed Early-onset Neonatal Sepsis
Time frame: From birth till 7 days of life.
Infection-related Neonatal Hospitalisation Longer Than 5 Days or Readmission
Time frame: From birth until 42 days of life.
Placental Chorioamniotic Tissue Culture
Time frame: At delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Background: PubMed 8879841Rutanen EM, Karkkainen TH, Lehtovirta J, Uotila JT, Hinkula MK, Hartikainen AL. Evaluation of a rapid strip test for insulin-like growth factor binding protein-1 in the diagnosis of ruptured fetal membranes. Clin Chim Acta. 1996 Sep 30;253(1-2):91-101. doi: 10.1016/0009-8981(96)80001-e.
- Background: PubMed 36464667Abu Shqara R, Bussidan S, Glikman D, Rechnitzer H, Lowenstein L, Frank Wolf M. Clinical implications of uterine cultures obtained during urgent caesarean section. Aust N Z J Obstet Gynaecol. 2023 Jun;63(3):344-351. doi: 10.1111/ajo.13630. Epub 2022 Dec 4.
- Background: PubMed 26819787Montelongo EM, Blue NR, Lee RH. Placenta Accreta in a Woman with Escherichia coli Chorioamnionitis with Intact Membranes. Case Rep Obstet Gynecol. 2015;2015:121864. doi: 10.1155/2015/121864. Epub 2015 Dec 27.
- Background: PubMed 34343185Solomon S, Akeju O, Odumade OA, Ambachew R, Gebreyohannes Z, Van Wickle K, Abayneh M, Metaferia G, Carvalho MJ, Thomson K, Sands K, Walsh TR, Milton R, Goddard FGB, Bekele D, Chan GJ. Prevalence and risk factors for antimicrobial resistance among newborns with gram-negative sepsis. PLoS One. 2021 Aug 3;16(8):e0255410. doi: 10.1371/journal.pone.0255410. eCollection 2021.
- Background: PubMed 24141714World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.
- Background: PubMed 11168913Santschi EM, Papich MG. Pharmacokinetics of gentamicin in mares in late pregnancy and early lactation. J Vet Pharmacol Ther. 2000 Dec;23(6):359-63. doi: 10.1046/j.1365-2885.2000.00298.x.
- Background: PubMed 9376915Gribomont AC, Stragier A. [Idiopathic epimacular membrane and vitreo-macular traction syndrome: vitrectomy functional results]. Bull Soc Belge Ophtalmol. 1996;262:123-6. French.
- Background: PubMed 32847438Senat MV, Schmitz T, Bouchghoul H, Diguisto C, Girault A, Paysant S, Sibiude J, Lassel L, Sentilhes L. Term prelabor rupture of membranes: guidelines for clinical practice from the French College of Gynaecologists and Obstetricians (CNGOF). J Matern Fetal Neonatal Med. 2022 Aug;35(16):3105-3109. doi: 10.1080/14767058.2020.1810230. Epub 2020 Aug 27.
- Background: PubMed 9580172Cararach V, Botet F, Sentis J, Almirall R, Perez-Picanol E. Administration of antibiotics to patients with rupture of membranes at term: a prospective, randomized, multicentric study. Collaborative Group on PROM. Acta Obstet Gynecol Scand. 1998 Mar;77(3):298-302.
- Background: PubMed 8598837Hannah ME, Ohlsson A, Farine D, Hewson SA, Hodnett ED, Myhr TL, Wang EE, Weston JA, Willan AR. Induction of labor compared with expectant management for prelabor rupture of the membranes at term. TERMPROM Study Group. N Engl J Med. 1996 Apr 18;334(16):1005-10. doi: 10.1056/NEJM199604183341601.
- Background: PubMed 35438865Inducing labour. London: National Institute for Health and Care Excellence (NICE); 2021 Nov 4. Available from http://www.ncbi.nlm.nih.gov/books/NBK579537/
- Background: PubMed 28742677Committee Opinion No. 712: Intrapartum Management of Intraamniotic Infection. Obstet Gynecol. 2017 Aug;130(2):e95-e101. doi: 10.1097/AOG.0000000000002236.
- Malaysia's National Antibiotics GuidelinesLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because there is currently no formal data-sharing plan or repository arrangement for this investigator-initiated study.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ampicillin and Ampicillin + gentamicin in people with Rupture of Membranes Prior to Onset of Labor, run by Sarawak General Hospital at 3 sites in Malaysia.
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 11 inclusion and 15 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: opening soon, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Malaysia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jagdeesh Kaur Kaur, Medical Degree (+6 0122129958, jagdeesh_kaur@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Chorioamnionitis (time frame: From admission (diagnosis of PROM) until delivery (72 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07563504, which also lists 13 linked publications.
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 4 May 2026.