Home » Trials » SLCTR/2021/010
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
The date of last modification
Dec 22, 2023
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
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 ] |
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
2021-04-07
Date of study completion
Recruitment status
Recruiting
Funding source
Investigator
Regulatory approvals
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 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
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
