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The effect of oral glucose solution and mouth wetting with water versus fasting in the induction of labour in uncomplicated primigravid pregnancies: A randomized controlled study

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SLCTR Registration Number

SLCTR/2021/010


Date of Registration

02 Apr 2021

The date of last modification

Apr 05, 2021



Application Summary


Scientific Title of Trial

The effect of oral glucose solution and mouth wetting with water versus fasting in the induction of labour in uncomplicated primigravid pregnancies: A randomized controlled study


Public Title of Trial

The effect of oral glucose solution and mouth wetting with water versus fasting in the induction of labour in uncomplicated primigravid pregnancies: A randomized controlled study


Disease or Health Condition(s) Studied

Labour and nutrition


Scientific Acronym

None


Public Acronym

None


Brief title

The effect of oral glucose solution on induction of labour in uncomplicated primigravid pregnancies


Universal Trial Number

U1111-1237-7136


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

2020/EC/77


Trial Details


What is the research question being addressed?

What is the effect on the outcome of labour in primigravid women who are given oral glucose solution compared to fasting at the induction of labour?


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: Teaching Hospital Peradeniya. Method of Randomization: A computer generated random table will be used to allocate participants in to two groups. Each subject will be assigned a 3 digit number given according to computer generated random table. Randomization will be performed to divide into two groups according to odds and even numbers. Participants with odd numbers will be taken as the intervention arm. Intervention: Patients at the induction of labour according to the inclusion & exclusion criteria will be selected. At the time of induction of labour by artificial rupture of membranes the cervical dilatation of 2cm to 4 cm patients will be recruited with neither no clinical evidence of presumed foetal compromise such as meconium or blood stained liquor nor suspicious or pathological cardiotocographs (CTG). One group will be given an oral solution of 50% dextrose 50ml and they will be given mouth wetting with water as requested. The control group will remain nil by mouth throughout the labour. Both groups will be given intravenous hydration with the augmentation of labour adjusted by oxytocin infusion according to contractions and the CTG.


Inclusion criteria

• Females who undergo induction of labour at term • Primigravid females • No clinical evidence of presumed fetal compromise at the time of induction of labour- meconium or blood stained liquor/ suspicious or abnormal CTG • Cervical dilatation should be between 2cm to 4 cm • Mothers who do not have any medical disorders


Exclusion criteria

• Multiparity • Gestational diabetes • Patients with pregnancy induced hypertension/ chronic hypertension • Mothers who are not giving consent • Multiple pregnancies • Bad obstetric history • Mothers who are already diagnosed with psychiatric illnesses • Clinical evidence of presumed fetal compromise at the time of induction of labour- meconium or blood stained liquor/ suspicious or abnormal CTG • Spontaneous labour/ pre-labour rupture of membranes • Pre-term labour • Foetal growth restriction



Primary outcome(s)

1.

Duration of labour

[

after delivery

]
2.

Mode of delivery

[

after delivery

]
3.

APGAR score of the baby

[

after delivery

]
4.

Patients’ experience of pain by numerical rating scale

[

Within 24 hours of the delivery

]
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Secondary outcome(s)


Target number/sample size

384 (192 in each arm)


Countries of recruitment

Sri Lanka


Anticipated start date

2021-04-04


Anticipated end date

2022-04-04


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

Investigator


Regulatory approvals



State of Ethics Review Approval


Status

Approved


Date of Approval

2021-02-22


Approval number

2020/EC/77


Details of Ethics Review Committee

Name: Ethics Review Committee of the Faculty of Medicine, University of Peradeniya.
Institutional Address:Ethics Review Committee of the Faculty of Medicine, University of Peradeniya.
Telephone:+94812396361
Email: chairpersonierc@gmail.com

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

YMTY Wijeratne
Senior Registrar in Gynae-onco-surgery
Apeksha Hospital, Maharagama 10280
0112850253 Ext 2228
0718118449

hellasyapa@gmail.com

Contact Person for Public Queries

Dr S. K. Ranaraja
Consultant Obstetrician and Gynaecologist
Teaching Hospital Peradeniya Peradeniya 20400
0812388007
0777 802949

sisira2@hotmail.com


Primary study sponsor/organization







Secondary study sponsor (If any)







Trial Completion details


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

Yes


IPD sharing plan description

All individual participant data collected during the trial, after de-identification, study protocol, statistical analysis plan, informed consent form, clinical study report will be available immediately after publication for anyone who wishes to access such data for research purposes in an online space. . Following the completion of research work, data will be will be discussed with the relevant authorities regarding policy changes in the case of positive findings.


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