NCT01606774

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 28, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

February 6, 2017

Status Verified

February 1, 2017

Enrollment Period

1.8 years

First QC Date

May 24, 2012

Last Update Submit

February 3, 2017

Conditions

Pre-eclampsiaIntrauterine Growth Retardation

Outcome Measures

Primary Outcomes (1)

  • 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

    Gestational age 18-36 weeks

Study Arms (1)

Low risk patients

EXPERIMENTAL

Patients who agreed to 4 telemedicine obstetrical visits

Other: Modernized prenatal care

Interventions

Modernized prenatal careOTHER

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

Low risk patients

Eligibility Criteria

AgeUp to 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • 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.

    PMID: 21210474BACKGROUND

MeSH Terms

Conditions

Pre-EclampsiaFetal Growth Retardation

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFetal DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Allan S Nadel, MD

    Massachusetts General Hospital and Harvard Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Prenatal Diagnosis, Dept. of OB/GYN

Study Record Dates

First Submitted

May 24, 2012

First Posted

May 28, 2012

Study Start

July 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

February 6, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)