A Modernized Approach to Prenatal Care in Low Risk Women

Mass General Brigham

Status

Completed

Conditions

Intrauterine Growth Retardation

Pre-eclampsia

Treatments

Other: Modernized prenatal care

Study type

Interventional

Funder types

Other

Identifiers

NCT01606774

PNC2.0

Details and patient eligibility

About

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.

Enrollment

4 patients

Sex

Female

Ages

Under 35 years old

Volunteers

Accepts Healthy Volunteers

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).