Intrauterine Growth Retardation, Pre-eclampsia
Conditions
Brief summary
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.
Interventions
OTHERModernized prenatal care
Home monitoring/phone surveillance/28 week ultrasound in place of 4-5 routine prenatal visits between 18 and 36 weeks
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 35 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unanticipated pregnancy complications | Gestational age 18-36 weeks | Any maternal and/or fetal adverse outcome that was not detected, but could have been detected by routine antepartum visits between 18 and 36 weeks |
Countries
United States
Outcome results
None listed