Home » Trials » SLCTR/2019/033

Antibiotic prophylaxis for prelabour rupture of membrane (PROM) at term in pregnant women presented to Obstetric Professorial Unit of Teaching Hospital Mahamodara- A Randomized controlled trial


SLCTR Registration Number


Date of Registration

26 Sep 2019

The date of last modification

Sep 26, 2019

Application Summary

Scientific Title of Trial

Antibiotic prophylaxis for prelabour rupture of membrane (PROM) at term in pregnant women presented to Obstetric Professorial Unit of Teaching Hospital Mahamodara- A Randomized controlled trial

Public Title of Trial

A randomized controlled trial on the effectiveness of prophylactic antibiotics compared to standard therapy on prevention of feto maternal and neonatal infections.

Disease or Health Condition(s) Studied

Prelabour rupture of membrane(PROM)

Scientific Acronym


Public Acronym


Brief title


Universal Trial Number


Any other number(s) assigned to the trial and issuing authority


Trial Details

What is the research question being addressed?

Is prophylactic antibiotic therapy effective in reducing feto- maternal & neonatal infections compared to standard therapy in mothers who present with prelabour rupture of membrane at term (> 37 weeks of period of gestation)?

Type of study


Study design


Randomized controlled trial


Single blinded : Participants


Standard therapy/practice





Study Phase

Phase 3

Intervention(s) planned

Consecutive patients admitted to Obstetrics Professorial Unit of Teaching Hospital Mahamodara with PROM after 37 weeks of gestational age from 01/10/2019 until required sample is achieved. Eligible patients will recruited to the study after getting informed written consent. On admission random number (between 1- 160 ) will be selected by patients. If number is even , they will be allocated into intervention group. If number is odd, they will be allocated into control groups.
The intervention group will receive oral erythromycin 250 mg 6 hourly for 3 days since admission. The control group will not receive any prophylactic antibiotic. All women in both groups will be managed according to current practice protocol.

If spontaneous labour occurs within 12 hours, patients will be sent to labour room and routine care provided. If labour does not occur spontaneously after 12 hours, a sterile speculum examination & Modified Bishop Score (MBS) assessment will be done. If the cervix is unfavorable (MBS < 4), 3 mg prostaglandin will be inserted into the vagina after performing a cardiotocography, 6 hours prior to starting an oxytocin infusion. Digital vaginal examination will be avoided until the onset of active labour. In the labour room, induction of labour will be carried out according to the National Guideline for the use of oxytocin for induction & augmentation of labour.

Inclusion criteria

1.Women with PROM > 37 weeks and < 41 weeks of gestational age 2. Women with singleton fetus with cephalic presentation 3. Women with no uterine contraction on admission 4. Women with ruptured membrane less than 12 hours

Exclusion criteria

1.Contraindication for normal vaginal delivery 2.Planned EL/LSCS or indication for EM/ LSCS on admission 3.Death in utero or fetal anomaly 4.Contraindication for oxytocin or prostaglandins 5.Allergic to erythromycin 6. Presence of an indication to start Group B Streptococcal antibiotic prophylaxis

Primary outcome(s)


1.Chorioamnionitis: Diagnosed according to the southern Australian Perinatal Practice Guidelines a. Maternal pyrexia(>38C) & at least two of following b. Maternal tachycardia >100 bpm c. Fetal tachycardia > 160 bpm d. Uterine tenderness e. Offensive vaginal discharge f. CRP> 40 mg/ dL g. WBC count> 15*109/L


72 hours after delivery.

  1. Postpartum endometritis: diagnosed by pyrexia >38 C after 24 hours of delivery in the absence of other maternal cause with one of the following a. Uterine tenderness b. WBC count > 15*109/L c. CRP> 20 mg/ dL

72 hours after delivery.


3.Postpartum Sepsis - Diagnosed if mother has pyrexia > 38 C with positive blood culture


72 hours after delivery.

  1. Intrapartum fever

72 hours after delivery

  1. APGAR Score at 1st minute and 5th minute

To be measured 8 hourly for 72 hours

  1. Special care baby unit admissions and duration

To be measured 8 hourly for 72 hours

  1. Need for neonatal oxygen therapy & duration

To be measured 8 hourly for 72 hours

  1. Need for neonatal ventilation and duration

To be measured 8 hourly for 72 hours

  1. Need for neonatal intravenous antibiotics and duration

To be measured 8 hourly for 72 hours


10.Neonatal sepsis


To be measured 8 hourly for 72 hours


Secondary outcome(s)

Target number/sample size

160 ( 80 for each group)

Countries of recruitment

Sri Lanka

Anticipated start date


Anticipated end date


Date of first enrollment

Date of study completion

Recruitment status


Funding source

self funded

Regulatory approvals


State of Ethics Review Approval



Date of Approval


Approval number


Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medicine, University of Ruhuna
Institutional Address:P.O Box:70, Galle, Sri Lanka
Email: www.medi.ruh.ac.lk

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Dr. T. D. Ruchira Lasanga
Registrar ( Gynaecology & Obstetrics)
Professorial Unit- Gynaecology & Obstetrics, Teaching Hospital, Mahamodara.

Contact Person for Public Queries

Dr(Mrs) A. G.I. Mampitiya
Senior Lecturer in Obstetrician & Gynaecologist
Professorial unit Teaching Hospital, Mahamodara.



Primary study sponsor/organization

Professorial unit- Obstetics & Gynaecology

Teaching Hospital, Mahamodara.

Secondary study sponsor (If any)

Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?


IPD sharing plan description

Study protocol available


Protocol version and date

Not Available

Protocol URL

Not Available

Results summary available


Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results