Condition category
Pregnancy and Childbirth
Date applied
28/05/2019
Date assigned
11/06/2019
Last edited
11/06/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
75% of pregnant women experience some form of sleep disruption during pregnancy. The rate of sleep disturbances also increases across trimesters, ranging from 13% in the first trimester, 19% in the second, and 66% in the third. Lack of sleep in the third trimester has a detrimental effect on pregnancy outcomes. Women who reported less than 6 hours of sleep per night during the last month of pregnancy had a significantly longer mean duration of labour and a higher rate of caesarean births. Women who slept less than 7 hours at night are at increased risk of developing gestational diabetes, gestational hypertension and preterm birth. Eye masks and earplugs may help to improve spontaneous vaginal delivery among women who have never given birth before (nulliparas) in their third trimester. The aim of this study is to assess the impact of eye masks and earplugs compared to a headband as sleep aids among 34 to 36 weeks nulliparas.

Who can participate?
Nulliparas who attend the Antenatal Clinic at University Malaya Medical Centre, who sleep for less than 6 hours a night

What does the study involve?
Participants are randomly allocated to the intervention group or the sham method group. The intervention group are provided with eye masks and earplugs to wear when they go to bed at night up until the delivery. They may remove the eye masks and earplugs temporarily if they wake up from sleep at night. The sham method group are provided with an elasticated headband to wear when they go to bed at night up until the delivery. The headband shall be placed on their forehead loosely. At the end of 2 weeks, participants receive a call from the investigator to assess their sleep quality using a questionnaire. Participants are followed up until delivery to assess the rate of spontaneous vaginal delivery.

What are the possible benefits and risks of participating?
Patients may have improved sleep with sleeping aids and thus improved spontaneous vaginal delivery. There are no risks involved.

Where is the study run from?
University Malaya Medical Centre (Malaysia)

When is the study starting and how long is it expected to run for?
June 2019 to March 2020

Who is funding the study?
University Malay Medical Centre (Malaysia)

Who is the main contact?
1. Dr Vimaladevi Annamalai
devi_vimala25@siswa.um.edu.my
2. Prof. Tan Peng Chiong
tanpengchiong@yahoo.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Vimaladevi Annamalai

ORCID ID

Contact details

University Malaya Medical Centre
Lembah Pantai
Kuala Lumpur
50603
Malaysia
+60 (0)3 79494422
devi_vimala25@siswa.um.edu.my

Type

Scientific

Additional contact

Prof Tan Peng Chiong

ORCID ID

Contact details

University Malaya Medical Centre
Jalan Univeristy
Lembah Pantai
Kuala Lumpur
50603
Malaysia
+60 (0)123052970
tanpengchiong@yahoo.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

NMRR-19-590-47577

Study information

Scientific title

A randomized controlled trial on eye mask and earplugs compared to headband to improve night sleep and spontaneous vaginal delivery in nulliparas

Acronym

Study hypothesis

Use of earplugs and eye masks at 34-36 weeks during night time will improve spontaneous vaginal delivery among nulliparas.

Ethics approval

Approved 21/5/2019, Medical Research Ethics Committee of University Malaya Medical Centre (UMMC, Lembah Pantai, 59100, Kuala Lumpur, Malaysia; Tel: +60 (0)3 7949 3209; Email: umrec@um.edu.my), ref: MREC ID NO: 201936-7199

Study design

Prospective randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Spontaneous vaginal delivery among nulliparas

Intervention

Nulliparas who are at 34 - 36 weeks who attend the antenatal clinic in UMMC will be approached regarding this study. A patient information sheet will be provided for those who fulfil the initial eligibility criteria. Those who agree to participate will be asked to provide written consent. Randomisation with the intention to treat with a specific intervention or placebo sham method will follow. They will be randomised into two groups, interventional group or placebo using a sham method, based on a randomisation sequence generated using random.org in a random block of 4 or 8 sequence, generated by an investigator not involved in the recruitment process. Randomisation is by the opening of a sealed opaque and numbered envelope with lowest available envelope assigned in strict order.

Interventional Group:
Participants are provided with eye masks and earplugs to wear when they go to bed at night up till the delivery. They may remove the eye masks and earplugs temporarily if they wake up from sleep at night. At the end of 2 weeks, participants will receive a call from the investigator regarding sleep quality using a sleep questionnaire. They will be followed up until the delivery to analyse the spontaneous vaginal delivery as that is the primary objective.

Placebo Group:
Participants are provided with an elasticated headband to wear when they go to bed at night up until the delivery. The headband shall be placed on their forehead loosely. At the end of 2 weeks, participants will receive a call from the investigator regarding their sleep quality using a sleep questionnaire. They will be followed up until the delivery to analyse the spontaneous vaginal delivery as that is the primary objective.

Patients' labour and neonatal outcomes will be collected after they deliver.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Spontaneous vaginal delivery assessed using questionnaire in the data collection form upon delivery

Secondary outcome measures

Night sleep assessed using questionnaire form after 2 weeks

Overall trial start date

01/11/2018

Overall trial end date

01/03/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Nulliparous (no prior pregnancy ≥ 20 weeks)
2. 34-36 weeks of gestation
3. Self-reported sleep less than 6 hours
4. Singleton pregnancy
5. Access to the phone

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

234

Participant exclusion criteria

1. Patients with known pre-existing sleep disorders: chronic insomnia, sleep apnea
2. Patients with known pre-existing psychiatric disorders, e.g. depression, schizophrenia, etc
3. Patients with underlying medical disorders: SLE, thyroid disorders, epilepsy, heart disease
4. Planned caesarean delivery (e.g. placenta praevia , breech, maternal request)
5. Night shift workers or night care commitments
6. Active smoker
7. Current alcohol consumption
8. Maternal obesity >class II (BMI>35)
9. Intrauterine death
10. Care taker of other family members
11. Gross fetal anomaly

Recruitment start date

01/06/2019

Recruitment end date

30/11/2019

Locations

Countries of recruitment

Malaysia

Trial participating centre

University Malaya Medical Centre
Jalan Universiti, Lembah Pantai
Kuala LLumpur
50603
Malaysia

Sponsor information

Organisation

University Malaya Medical Centre

Sponsor details

Department of Obstetrics & Gynaecology
Jalan University
Lembah Pantai
Kuala Lumpur
50603
Malaysia
+60 (0)6 79492077
fomadmin@um.edu.my

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

University Malaya Medical Centre

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/12/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

11/06/2019: Uploaded protocol Version 2, 04 December 2017 (not peer reviewed). 04/06/2019: Trial's existence confirmed by research ethics committee.