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A Modernized Approach to Prenatal Care in Low Risk Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01606774
Recruitment Status : Completed
First Posted : May 28, 2012
Last Update Posted : February 6, 2017
Sponsor:
Information provided by (Responsible Party):
Allan Nadel, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE May 24, 2012
First Posted Date  ICMJE May 28, 2012
Last Update Posted Date February 6, 2017
Study Start Date  ICMJE July 2012
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2012)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Modernized Approach to Prenatal Care in Low Risk Women
Official Title  ICMJE A Modernized Approach to Prenatal Care in Low Risk Women
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Pre-eclampsia
  • Intrauterine Growth Retardation
Intervention  ICMJE Other: Modernized prenatal care
Home monitoring/phone surveillance/28 week ultrasound in place of 4-5 routine prenatal visits between 18 and 36 weeks
Study Arms  ICMJE Experimental: Low risk patients
Patients who agreed to 4 telemedicine obstetrical visits
Intervention: Other: Modernized prenatal care
Publications * Nicolaides KH. A model for a new pyramid of prenatal care based on the 11 to 13 weeks' assessment. Prenat Diagn. 2011 Jan;31(1):3-6. doi: 10.1002/pd.2685.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 3, 2017)
4
Original Estimated Enrollment  ICMJE
 (submitted: May 25, 2012)
80
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE up to 35 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01606774
Other Study ID Numbers  ICMJE PNC2.0
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Allan Nadel, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Allan S Nadel, MD Massachusetts General Hospital and Harvard Medical School
PRS Account Massachusetts General Hospital
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP