A Modernized Approach to Prenatal Care in Low Risk Women
Completed · Not applicable
Conditions studied: Pre-eclampsia, Intrauterine Growth Retardation
In brief
The investigators plan to identify 80 pregnant women at low risk for obstetrical complications and replace 4-5 routine third trimester visits with a structured program of home weight, blood pressure and urine protein monitoring along with regular structured phone interviews and a 28 week ultrasound. The investigators hypothesis is that this protocol is both safe and acceptable.
Key facts
- Study ID
- NCT01606774
- Run by
- Massachusetts General Hospital
- People needed
- 4
- Starts
- 2012-07-01
- Expected to finish
- 2014-04-01
- Last updated by the study team
- 2017-02-06
Who can join
Age: any, up to 35. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Age < 35
- Doesn't live alone
- Current phone number
- Previous pregnancy
- No prior second trimester miscarriage/fetal loss after 13 weeks
- Previous delivery
- If yes, all had uncomplicated antepartum course
- All Deliveries > 37 weeks
- All birth weight > 2700 grams
- Maternal BMI between 18.5 and 30
- No chronic medical problems
- No current substance abuse
- Spontaneous conception
- No family history of pre-eclampsia
- Agrees to first trimester aneuploidy screening
You may not qualify if…
- Clinically significant abnormalities on routine physical exam or routine laboratory results
- Multiple pregnancy
- Fetal abnormalities detected on either the 11-14 week or the 18 week ultrasound including a nuchal translucency > 3 mm but not including second trimester markers for aneuploidy or a low lying placenta
- A risk of fetal aneuploidy on first trimester screening > 1:300 PAPP-A < 5 %ile or HCG < 1 %ile (abnormalities of these serum analytes routinely obtained as part of aneuploidy screening are associated with an increased risk of adverse outcome)
- Elevated blood pressure (> 140/90),
- Cervical length < 3 cm at the 18 week ultrasound (which is associated with an increased risk for preterm delivery).
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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