Home » Trials » SLCTR/2014/001
Comparison of cervical massage with membrane sweeping for pre-induction cervical ripening at term- A Randomized Controlled Trial
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SLCTR Registration Number
SLCTR/2014/001
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Comparison of cervical massage with membrane sweeping for pre-induction cervical ripening at term- A Randomized Controlled Trial
Public Title of Trial
A study to compare two methods of inducing labour in full term pregnancy
Disease or Health Condition(s) Studied
Induction of labour
Scientific Acronym
none
Public Acronym
none
Brief title
none
Universal Trial Number
U1111-1147-7049
Any other number(s) assigned to the trial and issuing authority
None
What is the research question being addressed?
What is the effectiveness acceptability and maternal satisfaction of membrane sweeping compared to cervical massage for pre-induction cervical ripening at term?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Applicable
Intervention(s) planned
This study will be conducted at Unit B, Teaching Hospital Mahamodara, Galle.
Block randomization (primigravida, multigravida) will be used to allocate participants into 3 arms: Arm I (cervical massage), Arm II (membrane sweeping), and Arm III (control). Participants (period of gestation 40+4 days) will undergo vaginal examination by the first investigator. Arm I will receive cervical massage, Arm II will receive membrane sweeping while Arm III will undergo vaginal examination only. Participants found to have a Modified Bishop’s Score (MBS) >4 will be excluded from the study
Participants will be re-examined at period of gestation 40+6 days by a second investigator, who will be blind to the intervention. MBS will be determined and further intervention will be decided based on standard protocols.
Participants in Arm II who have a MBS of < 4 and where membrane sweeping is not possible due to a closed cervix and cannot admit finger, will be offered cervical massage. This group will be analyzed separately. Aseptic techniques will be adhered to during all procedures. Fetal well being will be monitored by daily cadiotocography, fetal movement charts and fetal heart sound monitoring three times a day by trained midwives.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Change in modified bishops score (MBS) |
[ At 40 week+6days of gestation . ] |
Secondary outcome(s)
|
1.
|
[ 1.First ten days post partum 2.Until discharge 3. Till spontaneous onset of labour 4. Delivery 5.Between 40 week + 4 days to 40 week+6 days 6. At 40 weeks and 6 days ] |
Target number/sample size
A sample size of 165 women (55 in each of the treatments and placebo groups) will be sufficient to detect a clinically important difference of 25% between groups
Countries of recruitment
Sri Lanka
Anticipated start date
2014-01-12
Anticipated end date
2014-10-01
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2013-09-16
Approval number
Not available
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Ruhuna |
| Institutional Address: | PO Box 70, Labuduwa Rd, Galle, Sri Lanka |
| Telephone: | +94-91-2234801/803 (Extension: 161) |
| Email: | ethics@med.ruh.ac.lk |
Contact person for Scientific Queries/Principal Investigator
DR.S.S.Yaddehige
Registar gynaecology and Obstetrics(medical officer)
Teaching Hospital Mahamodara,Galle,Srilanka.
0912222261
0718010277
0912222262
samanthayaddehige@yahoo.com
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
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
