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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

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SLCTR Registration Number

SLCTR/2019/033


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

None


Public Acronym

None


Brief title

None


Universal Trial Number

U1111-1240-1120


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

2019/P/031


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

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Single blinded : Participants


Control

Standard therapy/practice


Assignment

Parallel


Purpose

Prevention


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.

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.

]
2.
  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.

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

[

72 hours after delivery.

]
4.
  1. Intrapartum fever
[

72 hours after delivery

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

To be measured 8 hourly for 72 hours

]
6.
  1. Special care baby unit admissions and duration
[

To be measured 8 hourly for 72 hours

]
7.
  1. Need for neonatal oxygen therapy & duration
[

To be measured 8 hourly for 72 hours

]
8.
  1. Need for neonatal ventilation and duration
[

To be measured 8 hourly for 72 hours

]
9.
  1. Need for neonatal intravenous antibiotics and duration
[

To be measured 8 hourly for 72 hours

]
10.

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

2019-10-01


Anticipated end date

2020-09-30


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

self funded


Regulatory approvals

NMRA



State of Ethics Review Approval


Status

Approved


Date of Approval

2019-06-18


Approval number

2019/P/031


Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medicine, University of Ruhuna
Institutional Address:P.O Box:70, Galle, Sri Lanka
Telephone:091-2234801/803
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.
0912267052
0714599196
None
r.lasanga@gmail.com

Contact Person for Public Queries

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

0777921588

dr.ireshag@gmail.com


Primary study sponsor/organization

Professorial unit- Obstetics & Gynaecology

Teaching Hospital, Mahamodara.
0912223835


Secondary study sponsor (If any)







Trial Completion details


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

No


IPD sharing plan description


Study protocol available

No


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results