A Modernized Approach to Prenatal Care in Low Risk Women

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Pre-eclampsia Intrauterine Growth Retardation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Low risk patients

Patients who agreed to 4 telemedicine obstetrical visits

Group Type EXPERIMENTAL

Modernized prenatal care

Intervention Type OTHER

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

Interventions

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Modernized prenatal care

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

Intervention Type OTHER

Eligibility Criteria

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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).

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes