| CTRI Number |
CTRI/2014/12/005264 [Registered on: 08/12/2014] Trial Registered Retrospectively |
| Last Modified On: |
20/09/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [artificial ruputure of membranes] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of breaking the bag of waters on the duration of spontaneous labour |
|
Scientific Title of Study
|
Effect of amniotomy on the duration of spontaneous labour |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR VMALARVIZHI |
| Designation |
PG Registrar |
| Affiliation |
christian medical college, vellore |
| Address |
PG Registrar, Department of Obstetrics and Gynaecology, Unit-5, CMC Hospital, Vellore
PG Registrar, Department of Obstetrics and Gynaecology, Unit-5, CMC Hospital, Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
9894581716 |
| Fax |
|
| Email |
malarsbettu@cmcvellore.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jiji Elizabeth Mathew |
| Designation |
Head of Unit 5, Obstetrics and Gynaecology |
| Affiliation |
christian medical college, vellore |
| Address |
Unit 5, Department of Obstetrics and Gynaecology, Unit-5, CMC Hospital, Vellore
57-5/3,DOCTOR QUARTERS,5TH FLOOR, X-BLOCK ( MADURAM NIVAS )
CMC CAMPUS,CMC
Vellore
TAMIL NADU
632004
India |
| Phone |
04162283387 |
| Fax |
|
| Email |
og5@cmcvellore.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DR VMALARVIZHI |
| Designation |
PG Registrar |
| Affiliation |
christian medical college, vellore |
| Address |
PG Registrar, Department of Obstetrics and Gynaecology, Unit-5, CMC Hospital, Vellore
PG Registrar, Department of Obstetrics and Gynaecology, Unit-5, CMC Hospital, Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
9894581716 |
| Fax |
|
| Email |
malarsbettu@cmcvellore.ac.in |
|
|
Source of Monetary or Material Support
|
| Fluid Research Grant, Christian Medical College and hospital, Vellore, Tamil Nadu. |
|
|
Primary Sponsor
|
| Name |
Fluid Research Grant |
| Address |
Christian Medical College and hospital, Vellore, Tamil Nadu. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Malarvizhi |
Labour ward, Department of Obstetrics and Gynaecology |
Christian Medical College and hospital, Vellore, Tamil Nadu.
Vellore
TAMIL NADU |
9894581716
malarsbettu@cmcvellore.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Pregnant women in spontaneous labour, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Artificial rupture of membranes |
Breaking the bag of waters around the baby in women in spontaneous labour |
| Comparator Agent |
Not performing artificial rupture of membranes |
Allowing the membranes to stay intact either till they rupture spontaneously or at delivery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
• Low risk patient
• Singleton pregnancy
• Vertex presentation
• Membranes intact
• Cervical dilatation from 3-5 cm
• 37 – 41 weeks
• Spontaneous labour
|
|
| ExclusionCriteria |
| Details |
• Previous bad obstetric outcome
• Gestational diabetes
• Pre-eclampsia
• IUGR
• Previous LSCS
• Previous Uterine surgery
• HIV positive women
• Para 4 and more
• Presence of fetal heart abnormalities
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Duration of labour
|
One hour difference in duration of labour. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Caesarean Section
2. Need for oxytocin
3. Need for ARM
4. Hyperstimulation
5. FH abnormalities
6. Infection-Endometritis
7. Puerperal fever
8. Low APGAR score
9. NICU admission
10. Need for antibiotics
11. Sepsis
|
5% difference in caesarean section rate
5% decrease in need for oxytocin
5% difference in fetal heart abnormalities |
|
|
Target Sample Size
|
Total Sample Size="288"
Sample Size from India="288"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
02/08/2014 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Intentional artificial rupture of amniotic membranes is the most commonly performed procedure in modern obstetrics(1). It was first introduced by Thomas Denman, an English Obstetrician, in 1756. Mean length of first and second stage of labour was approximately 9 hours in nulli-parous women without regional analgesia and that the 95 percentile upper limit was 18.5 hours. The mean length of first and second stage of labour in multi- parous women without regional analgesia was 6 hours and that the 95 percentile upper limit was 13.5 hours.(2) The primary aim of amniotomy is to increase contractions and shorten the duration of labour. With amniotomy, the production and release of local prostaglandins and oxytocin increase resulting in stronger contractions and quicker cervical dilatation. In some centers, it is routinely performed in all women and in many centers it is used for treatment of prolonged labour(1). Amniotomy allows detection of meconium stained liquor. With the active management of labour protocol introduced by O’Driscoll in 1993, the use of amniotomy has been widely accepted as part of labour. It is thought that when the membranes are ruptured, the production and release of prostaglandins and oxytocin contribute towards shortening labour (3). Others argue that the protective water is important for cervical dilatation. However, there are number of potential but rare risks associated with amniotomy like cord prolapse, fetal heart rate abnormalities and sepsis. The Randomized Controlled Studies included in the Cochrane review (1) that compared outcomes in women who had amniotomy with outcomes in women who did not have amniotomy had variable inclusion criteria and hence have conflicting results. Thus, a need for a well-designed large study to look at the outcomes of this intervention has been identified as a research priority.
- Amniotomy for shortening spontaneous labor, Cochrane database of systematic reviews 2013, issue 6. Art.No: CD006167. DOI: 10.1002/14651858. CD006167 .pub4.
- Kilpatrick SJ, laros RK Jr: Characteristics of normal labour Obstet Gynecol 74:85,1989
- Busowski JD1, Parsons MT. Amniotomy to induce labor. Clin Obstet Gynecol. 1995 Jun;38(2):246-58.
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