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A Modernized Approach to Prenatal Care in Low Risk Women

Primary Purpose

Pre-eclampsia, Intrauterine Growth Retardation

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Modernized prenatal care

About this trial

This is an interventional diagnostic trial for Pre-eclampsia

Eligibility Criteria

undefined - 35 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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).

Sites / Locations

Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Low risk patients

Arm Description

Patients who agreed to 4 telemedicine obstetrical visits

Outcomes

Primary Outcome Measures

Unanticipated pregnancy complications

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01606774

First Posted

May 24, 2012

Last Updated

February 3, 2017

Sponsor

Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01606774

Brief Title

A Modernized Approach to Prenatal Care in Low Risk Women

Official Title

A Modernized Approach to Prenatal Care in Low Risk Women

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

July 2012 (undefined)

Primary Completion Date

April 2014 (Actual)

Study Completion Date

April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pre-eclampsia, Intrauterine Growth Retardation

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Low risk patients

Arm Type

Experimental

Arm Description

Patients who agreed to 4 telemedicine obstetrical visits

Intervention Type

Other

Intervention Name(s)

Modernized prenatal care

Intervention Description

Home monitoring/phone surveillance/28 week ultrasound in place of 4-5 routine prenatal visits between 18 and 36 weeks

Primary Outcome Measure Information:

Title

Unanticipated pregnancy complications

Description

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

Time Frame

Gestational age 18-36 weeks

10. Eligibility

Sex

Female

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

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 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Allan S Nadel, MD

Organizational Affiliation

Massachusetts General Hospital and Harvard Medical School

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

21210474

Citation

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. No abstract available.

Results Reference

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A Modernized Approach to Prenatal Care in Low Risk Women

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