A Modernized Approach to Prenatal Care in Low Risk Women

This study is not yet open for participant recruitment.
Verified May 2012 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Allan Nadel, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01606774
First received: May 24, 2012
Last updated: May 25, 2012
Last verified: May 2012
  Purpose

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
Pre-eclampsia
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
  Eligibility

Ages Eligible for Study:   up to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01606774

Contacts
Contact: Allan S Nadel, MD 617 724 9014 anadel@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Allan Nadel    617-724-9014    anadel@partners.org   
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Allan S Nadel, MD Massachusetts General Hospital and Harvard Medical School
  More Information

Publications:
Responsible Party: Allan Nadel, Director of Prenatal Diagnosis, Dept. of OB/GYN, Massachusetts General Hospital
ClinicalTrials.gov 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:
Eclampsia
Fetal Growth Retardation
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Fetal Diseases
Growth Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014