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Comparative effectiveness and maternal acceptability with cervical ripening using membrane sweep vs cervical massage: A randomized controlled clinical trial

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SLCTR Registration Number

SLCTR/2020/003


Date of Registration

22 Jan 2020

The date of last modification

Jan 22, 2020



Application Summary


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


Trial Details


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


Date of study completion


Recruitment status

Pending


Funding source

Self


Regulatory approvals

Ethics Review Committee of the Faculty of Medicine, University of Colombo.



State of Ethics Review Approval


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 & Sponsor Information


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


Primary study sponsor/organization



De Soysa Hospital for Women, Colombo, Sri Lanka.



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