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Clinical Trials/NCT01606774
NCT01606774
Completed
Not Applicable

A Modernized Approach to Prenatal Care in Low Risk Women

Massachusetts General Hospital1 site in 1 country4 target enrollmentJuly 2012
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ConditionsPre-eclampsiaIntrauterine Growth Retardation

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pre-eclampsia
Sponsor
Massachusetts General Hospital
Enrollment
4
Locations
1
Primary Endpoint
Unanticipated pregnancy complications
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2012
End Date
April 2014
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Allan Nadel

Director of Prenatal Diagnosis, Dept. of OB/GYN

Massachusetts General Hospital

Eligibility Criteria

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

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).

Outcomes

Primary Outcomes

Unanticipated pregnancy complications

Time Frame: 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

Study Sites (1)

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