An observational study in Infant, Small for Gestational Age, Infant, Low Birth Weight and Pregnancy, sponsored by IWK Health Centre. Completed at 1 site in Ghana. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-31.
Sponsored by IWK Health Centre · Observational
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.
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.
264 studies on the registry are indexed under Fetal Growth Retardation; 66 are open to participants now.
This study's enrollment of 162 is close to the median of 161 across 142 observational studies indexed under Fetal Growth Retardation.
Browse Fetal Growth Retardation studies →IWK Health Centre is the lead sponsor of 83 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The participants (subjects) will be healthy, Ghanaian women who have recently delivered a live birth at KBTH. The inclusion/exclusion criteria criteria will be similar to the Ghana PrenaBelt Trial with one difference (* below) and one additional inclusion criterion (** below).
Exclusion Criteria:
Healthy, Ghanaian women who have recently delivered a live birth at the Korle Bu Teaching Hospital. No interventions will be administered.
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.
Time frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)
Customized Birth Weight Centile
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.
Time frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)
Gestational Age at Delivery
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.
Time frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)
Small for Gestational Age
Small for Gestational Age is defined as a birthweight centile ≤10th centile per the Gestation-Related Optimal Weight (GROW) standard.
Time frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)
Low Birth Weight
Low birth weight is defined has birth weight ≤ 2500 grams.
Time frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)
Sex of Newborn
Sex of participant's newborn.
Time frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)
Preterm Delivery
Preterm delivery is defined as gestational age at birth \<37 weeks.
Time frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)
Mode of Delivery
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.
Time frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)
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.
| Milestone | Controls |
|---|---|
| Started | 162 |
| Completed | 162 |
| Not completed | 0 |
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.
| grams | Controls |
|---|---|
| Birth Weight of Baby | 3033 ± 514 |
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.
| percentile | Controls |
|---|---|
| Customized Birth Weight Centile | 46.0 ± 30.5 |
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.
| Weeks | Controls |
|---|---|
| Gestational Age at Delivery | 38.3 ± 2.5 |
Small for Gestational Age is defined as a birthweight centile ≤10th centile per the Gestation-Related Optimal Weight (GROW) standard.
| Participants | Controls |
|---|---|
| Small for Gestational Age | 25 |
Low birth weight is defined has birth weight ≤ 2500 grams.
| Participants | Controls |
|---|---|
| Low Birth Weight | 21 |
Sex of participant's newborn.
| Participants | Controls |
|---|---|
| Male | 82 |
| Female | 80 |
Preterm delivery is defined as gestational age at birth \<37 weeks.
| Participants | Controls |
|---|---|
| Preterm Delivery | 42 |
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.
| Participants | Controls |
|---|---|
| Spontaneous vaginal | 122 |
| Caesarean section | 40 |
| Instrumented | 0 |
Collected over From delivery of infant (spontaneous vaginal delivery, instrumented vaginal delivery, cesarean section delivery) through discharge of the participant from hospital, which was 24 hours for a spontaneous vaginal delivery and 48 hours for an instrumented vaginal delivery or cesarean section delivery.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Controls | 0/162 (0%) | 0/162 (0%) | 0/162 (0%) |
| Age, Continuous(years) | Controls |
|---|---|
| Mean | 28.7 ± 4.4 |
| Sex: Female, Male(Participants) | Controls |
|---|---|
| Female | 162 |
| Male | 0 |
| Race/Ethnicity, Customized(Participants) | Controls |
|---|---|
| Ghanaian | 162 |
| Region of Enrollment(Participants) | Controls |
|---|---|
| Ghana | 162 |
| Gravidity(Participants) | Controls |
|---|---|
| Gravida 1 | 33 |
| Gravida ≥2 | 129 |
| Parity(Participants) | Controls |
|---|---|
| Para 1 | 44 |
| Para ≥2 | 118 |
| Education level(Participants) | Controls |
|---|---|
| Tertiary | 21 |
| Vocational | 1 |
| Senior High | 52 |
| Junior High | 57 |
| Primary | 30 |
| Undisclosed | 1 |
| Household Income(Cedis per month) | Controls |
|---|---|
| Mean | 1144 ± 665 |
13 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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