KBTH-GIRHL Healthy Birth Weight Study: A Cross-Section

Korle Bu Teaching Hospital - Global Innovations for Reproductive Health & Life Healthy Birth Weight Study: A Cross-Section

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03062228

Acronym

KBTH-HBWS

Enrollment

162

Registered

2017-02-23

Start date

2016-04-28

Completion date

2017-03-01

Last updated

2020-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Growth Retardation, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Very Low Birth Weight, Pregnancy, Sleep

Keywords

stillbirth, sleep, low birth weight, pregnancy, supine, small for gestational age

Brief summary

This study was designed and conducted in an effort to establish a comparison group for the Ghana PrenaBelt Trial (NTC02379728). The Ghana PrenaBelt Trial examined the effect, on birth weight, of a belt-like device to help pregnant women to avoid sleeping on their back during sleep in the third trimester. This study will seek to establish the typical birth weight of babies born to a cohort of healthy pregnant Ghanian women who are similar in characteristics to the women in the Ghana PrenaBelt Trial but who have not been educated to avoid back sleep during pregnancy nor have received a device to prevent back sleep.

Detailed description

Recently, three studies have suggested that maternal back sleep may be a risk factor for stillbirth (SB) and low birth weight (LBW). This is significant given that the majority of third-trimester pregnant women spend up to 25% of their sleep time on their back. The Ghana PrenaBelt Trial (GPT), completed by our team at the Korle Bu Teaching Hospital (KBTH) from September 2015 - May 2016, was the first interventional trial investigating this possible relationship between maternal back sleep and LBW. However, a limitation of the GPT was that due to its sham-control design, all participants in the trial (treatment group and sham-control group) were educated during the consent process about back-sleep in late pregnancy as a possible risk factor for SB and LBW. At interim analysis of the GPT (February 2016), no difference in birth weight was found between the two groups. Also around this time, the study team had anecdotal reports from sham-group participants who indicated that they trained themselves to sleep exclusively on their left side. Further, there is evidence in the literature that when instructed to sleep on their left, third-trimester pregnant women can increase the percentage of left-sided sleep to approximately 60% of the night on average and maintain this across multiple nights. Given this, it was questioned if the back-sleep education during the consent process could be having an effect on the sleep behaviour of the GPT participants independently of their treatment allocation; therefore, the KBTH-GIRHL Healthy Birth Weight Study was designed in March 2016 to investigate this question further. The aim of this study is to establish a reference birth weight of babies born to a cohort of women comparable to the cohort in the GPT but who have not received back-sleep education, did not participate in the GPT, and whose babies were born in a similar time period and weighed on the same newborn scales - in essence, a control group for the GPT. This cross-sectional study will be accomplished via recruiting a control group from a pool of women having recently delivered at KBTH, reviewing their hospital records, and having them complete a short survey about their demographics, obstetric history, and sleep behaviors. The results of this study, together with the results of the GPT, will enable us to determine whether or not education about back-sleep in pregnancy affects pregnancy outcomes, specifically birth weight.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

Healthy volunteers

Yes

Inclusion criteria

* Low-risk singleton pregnancy * \*Delivered a live birth \>28 weeks gestation at KBTH within the past 48 hours. * Residing in the Greater Accra Metropolitan Area or area served by the KBTH. * Fluent in either English, Twi, or Ga * \*\*Has not received education/ information about back sleep position in pregnancy as a potential risk factor for stillbirth and low birth weight.

Exclusion criteria

* BMI ≥ 35 at booking (first antenatal appointment for current pregnancy) * Pregnancy complicated by obstetric complications (hypertension \[pre-eclampsia, gestational hypertension, chronic hypertension\], diabetes \[gestational or not\], or intra-uterine growth restriction \[\<10th %ile for growth\]) * Sleep complicated by medical conditions (known to get \<4 hours of sleep per night due to insomnia, or musculoskeletal disorder that prevents sleeping on a certain side \[e.g., arthritic shoulder\]) * Multiple pregnancy * Known fetal abnormality * Maternal age \>35

Design outcomes

Primary

Measure	Time frame	Description
Birth Weight of Baby	Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)	At delivery, birth weight will be measured and recorded in the participant's health record as a part of routine obstetric care at the Korle Bu Teaching Hospital.
Customized Birth Weight Centile	Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)	Individual customized birth weight centile calculated using the Gestation Network (Perinatal Institute; Birmingham, UK) Bulk Centile Calculator (BCC), which calculates customized birthweight centiles using the principles of the Gestation Related Optimal Weight (GROW) method. The main non-pathological factors affecting birth weight are gestational age, maternal height, maternal weight at booking, parity, and ethnic group. The sex of fetus/neonate, when known, should also be adjusted for. These six variables need to be adjusted for to calculate the true growth potential, which can be represented as individually customized fetal growth curves and birth weight percentiles using the principles of the GROW. This method for calculating growth potential has been validated in a number of international studies.

Secondary

Measure	Time frame	Description
Low Birth Weight	Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)	Low birth weight is defined has birth weight ≤ 2500 grams.
Sex of Newborn	Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)	Sex of participant's newborn.
Gestational Age at Delivery	Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)	Gestational age at delivery (weeks) will be recorded in the participant's health record as a part of routine obstetric care at the Korle Bu Teaching Hospital.
Mode of Delivery	Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)	Mode of delivery (spontaneous vaginal, Cesarean section, instrumented) will be recorded in the participant's health record as a part of routine obstetric care at the Korle Bu Teaching Hospital.
Preterm Delivery	Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)	Preterm delivery is defined as gestational age at birth \<37 weeks.
Small for Gestational Age	Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)	Small for Gestational Age is defined as a birthweight centile ≤10th centile per the Gestation-Related Optimal Weight (GROW) standard.

Countries

Ghana

Participant flow

Recruitment details

Participants were recruited between April 28 2016 through February 22 2017, inclusive. Participants were recruited by the study recruiter from a sample of healthy, Ghanaian women presenting to the KBTH maternity wards and who delivered a live birth within the past 48 hours.

Pre-assignment details

There were no significant events in the study after participant enrollment but prior to assignment to an arm or group. Two participants who were recruited were excluded from the study after it was discovered later that they did not fully meet the eligibility criteria (both had delivered stillborn infants).

Participants by arm

Arm	Count
Controls Healthy, Ghanaian women who have recently delivered a live birth at the Korle Bu Teaching Hospital. No interventions will be administered.	162
Total	162

Baseline characteristics

Characteristic	Controls
Age, Continuous	28.7 years STANDARD_DEVIATION 4.4
BMI upon entering third trimester for current pregnancy	27.7 kg/m^2 STANDARD_DEVIATION 4.1
Education level Junior High	57 Participants
Education level Primary	30 Participants
Education level Senior High	52 Participants
Education level Tertiary	21 Participants
Education level Undisclosed	1 Participants
Education level Vocational	1 Participants
Gravidity Gravida 1	33 Participants
Gravidity Gravida ≥2	129 Participants
Household Income	1144 Cedis per month STANDARD_DEVIATION 665
In the last week, sleep onset position Left	75 Participants
In the last week, sleep onset position Prone	0 Participants
In the last week, sleep onset position Right	76 Participants
In the last week, sleep onset position Supine	11 Participants
In the last week, waking position Left	67 Participants
In the last week, waking position Prone	0 Participants
In the last week, waking position Right	70 Participants
In the last week, waking position Supine	25 Participants
Nightly sleep duration	8.3 hours STANDARD_DEVIATION 1.5
Parity Para 1	44 Participants
Parity Para ≥2	118 Participants
Part of bed sleeps on Center	1 Participants
Part of bed sleeps on Left	50 Participants
Part of bed sleeps on Other	3 Participants
Part of bed sleeps on Right	108 Participants
Past medical complications	4 Participants
Pillow use Behind back	0 Participants
Pillow use Between knees	1 Participants
Pillow use None	16 Participants
Pillow use Pregnancy pillow	0 Participants
Pillow use Under feet	37 Participants
Pillow use Under head	146 Participants
Pillow use Under legs	0 Participants
Pillow use Under tummy	0 Participants
Pre-pregnancy BMI	25.8 kg/m^2 STANDARD_DEVIATION 3.9
Race/Ethnicity, Customized Ghanaian	162 Participants
Region of Enrollment Ghana	162 Participants
Sex: Female, Male Female	162 Participants
Sex: Female, Male Male	0 Participants
Sleeps with bed partner	119 Participants
Snores ≥3 nights per week	12 Participants
Uses insecticide treated bed net	50 Participants
When not pregnant, sleep onset position Left	1 Participants
When not pregnant, sleep onset position Prone	50 Participants
When not pregnant, sleep onset position Right	24 Participants
When not pregnant, sleep onset position Supine	87 Participants
When not pregnant, waking position Left	0 Participants
When not pregnant, waking position Prone	34 Participants
When not pregnant, waking position Right	31 Participants
When not pregnant, waking position Supine	97 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 162
other Total, other adverse events	0 / 162
serious Total, serious adverse events	0 / 162

Outcome results

Primary

Birth Weight of Baby

At delivery, birth weight will be measured and recorded in the participant's health record as a part of routine obstetric care at the Korle Bu Teaching Hospital.