A Modernized Approach to Prenatal Care in Low Risk Women



Status:Completed
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:Any - 35
Updated:4/2/2016
Start Date:July 2012
End Date:December 2013
Contact:Allan S Nadel, MD
Email:anadel@partners.org
Phone:617 724 9014

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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.


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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).
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
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