N/A
N=162
KBTH-GIRHL Healthy Birth Weight Study: A Cross-Section
Infant, Small for Gestational Age · Infant, Low Birth Weight · Pregnancy · Sleep · Infant, Very Low Birth Weight
Bottom Line
View on ClinicalTrials.gov: NCT03062228 ↗Enrolled (actual)
162
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Birth Weight of Baby — 3033 grams
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- IWK Health Centre
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Birth Weight of Baby |
3033 | — |
| PRIMARY Customized Birth Weight Centile |
46.0 | — |
| SECONDARY Gestational Age at Delivery |
38.3 | — |
| SECONDARY Small for Gestational Age |
25 | — |
| SECONDARY Low Birth Weight |
21 | — |
| SECONDARY Sex of Newborn |
82; 80 | — |
| SECONDARY Preterm Delivery |
42 | — |
| SECONDARY Mode of Delivery |
122; 40; 0 | — |
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.
Eligibility Criteria
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 [ 35
Data sourced from ClinicalTrials.gov (NCT03062228). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.