Home » Trials » SLCTR/2020/003
Comparative effectiveness and maternal acceptability with cervical ripening using membrane sweep vs cervical massage: A randomized controlled clinical trial
-
SLCTR Registration Number
SLCTR/2020/003
Date of Registration
The date of last modification
Oct 02, 2020
Scientific Title of Trial
Comparative effectiveness and maternal acceptability with cervical ripening using membrane sweep vs cervical massage: A randomized controlled clinical trial
Public Title of Trial
Comparative effectiveness of and maternal acceptability with using cervical massage vs membrane sweep for cervical ripening in pregnant women from 38th week of gestation at a tertiary care unit: A randomized controlled trial
Disease or Health Condition(s) Studied
Obstetric care
Scientific Acronym
CEASELESS
Public Acronym
CEASELESS
Brief title
Comparative effectiveness and maternal acceptability with membrane sweep and cervical massage.
Universal Trial Number
U1111-1244-8026
Any other number(s) assigned to the trial and issuing authority
EC-19-064
What is the research question being addressed?
Is there a difference between ripening the uterine cervix using cervical massage or membrane sweep with regards to effectiveness and maternal acceptance?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Applicable
Intervention(s) planned
Study setting – Wards 3 and 15, De Soysa Hospital for Women, Sri Lanka.
Method of randomization - Research Randomizer available at https://www.randomizer.org/ will be used to generate three sets of random numbers. For the first set of numbers, membrane sweeping will be the allocated method of induction. For the second set of numbers, cervical massage will be the allocated method of induction. The third set will be allocated to the control group. Equal sized cards will be prepared and a random number with its allocated method of induction will be printed on each card. These cards will be kept locked in an opaque container in the ward. After a study participant signs the consent form, the next available sequential number will be extracted from the said container and the method mentioned will be administered as the method of induction of labour.
Eligible study participants will be allocated randomly to three study groups.
In Group S, membrane sweep will consist of insertion of one finger through the internal OS and performing three circumferential passes separating the chorio-amnion from the lower uterine segment.
In Group M, cervical massage consists of three circumferential passes of around the cervix massaging the cervix with examiner’s index and middle fingers for 15-30 seconds.
In Group C, none of the above methods will be used and theses women will be used as the control group for the study.
The membrane sweep or the cervical massage will be performed once at 39th and once at 40th weeks of gestation for primiparous women. The membrane sweep or the cervical massage will be performed once at 40th week of gestation for multiparous women.
Inclusion criteria
Recruited women will, i. Have a gestational age more than 38 completed weeks, ii. Not have a clear indication for elective or emergency caesarian section or early delivery iii. Have reassuring fetal conditions defined as having normal fetal growth parameters, doppler values and a normal cardio-tocogram. iv. Have a Modified Bishops’ Score greater than or equal to 6
Exclusion criteria
Women will be excluded if i. There is an intra uterine fetal demise, ii. Their membranes are ruptured, iii. Her fetus has polyhydramnios, iv. Her fetus has severe fetal anomalies, v. Have any contraindication for induction of labor such as Cephalo-pelvic disproportion, obstructive pelvic mass, major degree placenta previa or morbidly adherent placenta. vi. Known latex allergies (Latex gloves will be worn during certain procedures during the study).
Primary outcome(s)
|
1.
Percentages of primigravdae who progress to spontaneous labour as defined by a Modified Bishops’ Score of ?7 or ?2 moderate uterine contractions per 10 minutes by 40+6 weeks of gestation. |
[ Delivery or till 40+6 weeks of gestation ] |
|
2.
Percentages of multigravdae who progress to spontaneous labour as defined by a Modified Bishops’ Score of ≥7 or ≥2 moderate uterine contractions per 10 minutes by 40+6 weeks of gestation. |
[ Delivery or till 40+6 weeks of gestation ] |
|
3.
Percentage of primigravidea and multigravidea that did not go into spontaneous labour and needed formal mechanical or pharmacological induction at 40+6 |
[ Delivery or till 40+6 weeks of gestation ] |
|
4.
Mean score of a validated questionnaire assessing maternal acceptability in using membrane sweep or cervical massage for cervical ripening among primigravida and multigravida |
[ Delivery or till 40+6 weeks of gestation ] |
Secondary outcome(s)
|
1.
Number of women who had a closed cervical os that precluded the use of membrane sweep (percentage) |
[ Delivery or till 40+6 weeks of gestation ] |
|
2.
Time from membrane sweep or cervical massage to delivery (For each intervention) hours |
[ Delivery or till 40+6 weeks of gestation ] |
|
3.
Vaginal delivery rate by 40 weeks and by 40+6 weeks for primigravidea after membrane sweep and after cervical massage. (percentage) |
[ Delivery or till 40+6 weeks of gestation ] |
|
4.
Vaginal delivery rate by 40+6 weeks for multigravidea after membrane sweep and after cervical massage (percentage) |
[ Delivery or till 40+6 weeks of gestation ] |
|
5.
Emergency caesarian section rates in women who underwent cervical massage and membrane sweep respectively (percentage) |
[ Delivery or till 40+6 weeks of gestation ] |
|
6.
Percentage of oxytocin augmentation in women who underwent cervical massage and membrane sweep respectively |
[ Delivery or till 40+6 weeks of gestation ] |
|
7.
Percentage of uterine hyperstimulation |
[ Delivery or till 40+6 weeks of gestation ] |
|
8.
Percentage of post-partum hemorrhage |
[ Delivery or till 40+6 weeks of gestation ] |
|
9.
Percentage of maternal fever |
[ Delivery or till 40+6 weeks of gestation ] |
|
10.
Duration of hospital stay in days |
[ Delivery or till 40+6 weeks of gestation ] |
|
11.
Maternal satisfaction score |
[ Delivery or till 40+6 weeks of gestation ] |
Target number/sample size
300 (3 arms 100 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2020-02-15
Anticipated end date
2020-05-31
Date of first enrollment
2020-02-20
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
Self
Regulatory approvals
Ethics Review Committee of the Faculty of Medicine, University of Colombo.
Status
Approved
Date of Approval
2019-10-17
Approval number
EC-19-064
Details of Ethics Review Committee
| Name: | Ethics Review Committee of the Faculty of Medicine, University of Colombo. |
| Institutional Address: | Ethics Review Committee, Faculty of Medicine, University of Colombo. PO BOX 271, Kinsey Road, Colombo 8, Sri Lanka |
| Telephone: | 0112695300 |
| Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr T M S S B Madugalle
Registrar in Obstetrics and Gynaecology
De Soysa Hospital for Women, Colombo, Sri Lanka
+94112 662 619
+94776748181
cinla007@yahoo.com
Contact Person for Public Queries
Dr D M C S Jayasundara
Hon. Consultant Obstetrician and Gynaecologist and Senior Lecturer
Professorial Obstetrics and Gynaecology unit
De Soysa Hospital for Women, Colombo, Sri Lanka
+94112 695300 ext 161
+94773753151
chandanasj@yahoo.com
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
