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| Name | Class |
|---|---|
| Korle Bu Teaching Hospital | UNKNOWN |
| University of Michigan | OTHER |
| Innovative Canadians for Change | OTHER |
| Dalhousie University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Controls | Healthy, Ghanaian women who have recently delivered a live birth at the Korle Bu Teaching Hospital. No interventions will be administered. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) |
| Small for Gestational Age |
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Inclusion Criteria:
Exclusion Criteria:
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Maxfield Okere, B.Sc. | Korle Bu Teaching Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korle Bu Teaching Hospital | Korle Bu | Accra | Ghana |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23507553 | Background | Owusu JT, Anderson FJ, Coleman J, Oppong S, Seffah JD, Aikins A, O'Brien LM. Association of maternal sleep practices with pre-eclampsia, low birth weight, and stillbirth among Ghanaian women. Int J Gynaecol Obstet. 2013 Jun;121(3):261-5. doi: 10.1016/j.ijgo.2013.01.013. Epub 2013 Mar 15. | |
| 21673002 | Background |
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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 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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Controls | Healthy, Ghanaian women who have recently delivered a live birth at the Korle Bu Teaching Hospital. No interventions will be administered. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Controls | Healthy, Ghanaian women who have recently delivered a live birth at the Korle Bu Teaching Hospital. No interventions will be administered. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Healthy, Ghanaian women who had recently (within 48 hours) delivered a live birth at the Korle Bu Teaching Hospital. | Posted | Mean | Standard Deviation | grams | Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) |
|
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Controls | Healthy, Ghanaian women who have recently delivered a live birth at the Korle Bu Teaching Hospital. No interventions will be administered. |
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Reliance on participant's self reports for some baseline characteristics data (e.g., pre-pregnancy BMI, sleep positions).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Allan Kember, Director of Programs | Global Innovations for Reproductive Health & Life | +1-902-580-8385 | allan.kember@mail.utoronto.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 20, 2016 | Jun 13, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 20, 2016 | Jun 13, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D005317 | Fetal Growth Retardation |
| D050497 | Stillbirth |
| D008192 | Deception |
| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| OTHER |
| Global Innovations for Reproductive Health & Life | UNKNOWN |
| University of Ghana Medical School | OTHER |
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Small for Gestational Age is defined as a birthweight centile ≤10th centile per the Gestation-Related Optimal Weight (GROW) standard. |
| 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. | Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) |
| Sex of Newborn | Sex of participant's newborn. | 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. | 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. | Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) |
| Stacey T, Thompson JM, Mitchell EA, Ekeroma AJ, Zuccollo JM, McCowan LM. Association between maternal sleep practices and risk of late stillbirth: a case-control study. BMJ. 2011 Jun 14;342:d3403. doi: 10.1136/bmj.d3403. |
| 25568999 | Background | Gordon A, Raynes-Greenow C, Bond D, Morris J, Rawlinson W, Jeffery H. Sleep position, fetal growth restriction, and late-pregnancy stillbirth: the Sydney stillbirth study. Obstet Gynecol. 2015 Feb;125(2):347-355. doi: 10.1097/AOG.0000000000000627. |
| 24885461 | Background | Platts J, Mitchell EA, Stacey T, Martin BL, Roberts D, McCowan L, Heazell AE. The Midland and North of England Stillbirth Study (MiNESS). BMC Pregnancy Childbirth. 2014 May 21;14:171. doi: 10.1186/1471-2393-14-171. |
| 24731396 | Background | Warland J, Mitchell EA. A triple risk model for unexplained late stillbirth. BMC Pregnancy Childbirth. 2014 Apr 14;14:142. doi: 10.1186/1471-2393-14-142. |
| 24661447 | Background | O'Brien LM, Warland J. Typical sleep positions in pregnant women. Early Hum Dev. 2014 Jun;90(6):315-7. doi: 10.1016/j.earlhumdev.2014.03.001. Epub 2014 Mar 21. |
| 27871127 | Background | Stone PR, Burgess W, McIntyre JP, Gunn AJ, Lear CA, Bennet L, Mitchell EA, Thompson JM; Maternal Sleep In Pregnancy Research Group, The University of Auckland. Effect of maternal position on fetal behavioural state and heart rate variability in healthy late gestation pregnancy. J Physiol. 2017 Feb 15;595(4):1213-1221. doi: 10.1113/JP273201. Epub 2016 Dec 11. |
| 25535960 | Background | Warland J, Dorrian J. Accuracy of self-reported sleep position in late pregnancy. PLoS One. 2014 Dec 23;9(12):e115760. doi: 10.1371/journal.pone.0115760. eCollection 2014. |
| 1346292 | Background | Gardosi J, Chang A, Kalyan B, Sahota D, Symonds EM. Customised antenatal growth charts. Lancet. 1992 Feb 1;339(8788):283-7. doi: 10.1016/0140-6736(92)91342-6. |
| 8521065 | Background | Gardosi J, Mongelli M, Wilcox M, Chang A. An adjustable fetal weight standard. Ultrasound Obstet Gynecol. 1995 Sep;6(3):168-74. doi: 10.1046/j.1469-0705.1995.06030168.x. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Gravidity | Count of Participants | Participants |
|
| Parity | Count of Participants | Participants |
|
| Education level | Count of Participants | Participants |
|
| Household Income | Average currency exchange rate for recruitment period: 1 United States Dollar (USD) = 4.04 Cedis | Two participants did not wish to disclose this information. | Mean | Standard Deviation | Cedis per month |
|
| BMI upon entering third trimester for current pregnancy | This is the participants BMI in the period between 26 and 30 weeks' gestation for the current pregnancy. | Mean | Standard Deviation | kg/m^2 |
|
| Pre-pregnancy BMI | BMI at the beginning of the current pregnancy | Mean | Standard Deviation | kg/m^2 |
|
| Nightly sleep duration | This is the participant's self-reported average nightly sleep duration in the past week. | Mean | Standard Deviation | hours |
|
| In the last week, sleep onset position | Count of Participants | Participants |
|
| In the last week, waking position | Count of Participants | Participants |
|
| When not pregnant, sleep onset position | Count of Participants | Participants |
|
| When not pregnant, waking position | Count of Participants | Participants |
|
| Part of bed sleeps on | Count of Participants | Participants |
|
| Pillow use | Count of Participants | Participants |
|
| Sleeps with bed partner | Count of Participants | Participants |
|
| Uses insecticide treated bed net | Count of Participants | Participants |
|
| Snores ≥3 nights per week | Count of Participants | Participants |
|
| Past medical complications | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | 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. | Healthy, Ghanaian women who had recently (within 48 hours) delivered a live birth at the Korle Bu Teaching Hospital. | Posted | Mean | Standard Deviation | percentile | Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) |
|
|
|
| Secondary | 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. | Healthy, Ghanaian women who had recently (within 48 hours) delivered a live birth at the Korle Bu Teaching Hospital. | Posted | Mean | Standard Deviation | Weeks | Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) |
|
|
|
| Secondary | Small for Gestational Age | Small for Gestational Age is defined as a birthweight centile ≤10th centile per the Gestation-Related Optimal Weight (GROW) standard. | Healthy, Ghanaian women who had recently (within 48 hours) delivered a live birth at the Korle Bu Teaching Hospital. | Posted | Count of Participants | Participants | Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) |
|
|
|
| Secondary | Low Birth Weight | Low birth weight is defined has birth weight ≤ 2500 grams. | Healthy, Ghanaian women who had recently (within 48 hours) delivered a live birth at the Korle Bu Teaching Hospital. | Posted | Count of Participants | Participants | Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) |
|
|
|
| Secondary | Sex of Newborn | Sex of participant's newborn. | Healthy, Ghanaian women who had recently (within 48 hours) delivered a live birth at the Korle Bu Teaching Hospital. | Posted | Count of Participants | Participants | Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) |
|
|
|
| Secondary | Preterm Delivery | Preterm delivery is defined as gestational age at birth <37 weeks. | Healthy, Ghanaian women who had recently (within 48 hours) delivered a live birth at the Korle Bu Teaching Hospital. | Posted | Count of Participants | Participants | Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) |
|
|
|
| Secondary | 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. | Healthy, Ghanaian women who had recently (within 48 hours) delivered a live birth at the Korle Bu Teaching Hospital. | Posted | Count of Participants | Participants | Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation) |
|
|
|
| 0 |
| 162 |
| 0 |
| 162 |
| 0 |
| 162 |
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| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006130 | Growth Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005313 | Fetal Death |
| D003643 | Death |
| D012919 | Social Behavior |
| D001519 | Behavior |