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A Modernized Approach to Prenatal Care in Low Risk Women

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2012 by Massachusetts General Hospital.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Allan Nadel, Massachusetts General Hospital Identifier:
First received: May 24, 2012
Last updated: May 25, 2012
Last verified: May 2012
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.

Condition Intervention
Intrauterine Growth Retardation
Other: Modernized prenatal care

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Modernized Approach to Prenatal Care in Low Risk Women

Resource links provided by NLM:

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Unanticipated pregnancy complications [ Time Frame: Gestational age 18-36 weeks ] [ Designated as safety issue: Yes ]
    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

Estimated Enrollment: 80
Study Start Date: July 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Modernized prenatal care
    Home monitoring/phone surveillance/28 week ultrasound in place of 4-5 routine prenatal visits between 18 and 36 weeks

Ages Eligible for Study:   up to 35 Years   (Child, Adult)
Genders Eligible for Study:   Female
Accepts 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).
  Contacts and Locations
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Please refer to this study by its identifier: NCT01606774

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Allan S Nadel, MD Massachusetts General Hospital and Harvard Medical School
  More Information

Responsible Party: Allan Nadel, Director of Prenatal Diagnosis, Dept. of OB/GYN, Massachusetts General Hospital Identifier: NCT01606774     History of Changes
Other Study ID Numbers: PNC2.0 
Study First Received: May 24, 2012
Last Updated: May 25, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fetal Growth Retardation
Hypertension, Pregnancy-Induced
Pregnancy Complications
Fetal Diseases
Growth Disorders
Pathologic Processes processed this record on January 14, 2017