Treatment for High Risk Pregnancies

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Pennsylvania, Philadelphia, PA
Eligibility
18+
Female
Eligible conditions
High Risk Pregnancies

Study Summary

This study is evaluating whether an online class can help improve pregnancy outcomes for women with high risk pregnancies.

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 14 secondary outcomes in patients with High Risk Pregnancies. Measurement will happen over the course of one-time score at 4-6 weeks postpartum.

4-6 weeks postpartum
Difference in breastfeeding rates postpartum
Difference in contraceptive uptake postpartum
Time of birth
Difference in APGAR scores
Number of infants with a NICU admission
Number of infants with a need for neonatal respiratory support outside the delivery room
Time of delivery
Number of participants who have Preterm birth
Week 40
Difference in intention to breastfeed
Day 3
Difference in contraceptive uptake at discharge from hospital
delivery
Mode of delivery
Week 6
Number of participants with hypertensive disorders of pregnancy
Number of participants with maternal readmission
Week 6
Difference in Edinburgh Postnatal Depression Scale
time of discharge from hospital after delivery
Difference in breastfeeding rates at discharge after delivery
time of enrollment through 6-week postpartum
Difference in healthcare utilization
Week 40
Change in PrAS score

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Birthly plus standard of care
Placebo group

This trial requires 90 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Birthly plus standard of care
Other
Women will receive a code to sign up for childbirth education classes through the Birthly platform. They will also participate in childbirth education at their own discretion.
Standard of Care
Other
Women will not receive a code for the 3 Birthly courses. They will participate in childbirth education at their own discretion.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: time of enrollment to 34-40 weeks gestation
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly time of enrollment to 34-40 weeks gestation for reporting.

Closest Location

University of Pennsylvania - Philadelphia, PA

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Women over 18
Willing and stable to give consent
English-speaking
Have access to high-speed internet available on a computer or mobile device
Nulliparous women have a confirmed single, live intrauterine gestation and are <20 weeks gestational age at their prenatal visit
Women without indications for a scheduled cesarean delivery at the time of their index prenatal visit
Women who have a high-risk pregnancy, as defined by all maternal conditions including hypertension, diabetes, auto-immune disorders, seizure disorder, substance use, etc
Agree to participation in Birthly
Obtaining prenatal care in the University of Pennsylvania Health System

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get high risk pregnancies a year in the United States?

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About 42 million women (12.3% of all women seeking care for all reasons within a given year) get at least one high risk pregnancy a year.

Unverified Answer

Can high risk pregnancies be cured?

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This case illustrates a successful management of recurrent high risk pregnancy and illustrates why it is important to have a close multidisciplinary, supportive care and rehabilitation pathway in place when managing this vulnerable group.

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What causes high risk pregnancies?

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Risk factors and causes of high risk pregnancies vary considerably between countries and regions of the world. Identifying the individual risk factors in various high risk groups in different regions and countries of the world will help in reducing the high risk pregnancies not only in high risk groups but also in the general population.

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What are the signs of high risk pregnancies?

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High risk pregnancies are characterized by signs of increased nuchal translucency and increased blood pressure. High risk pregnancies are also associated with signs of maternal and fetal hypoxia.

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What is high risk pregnancies?

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The most common complication is pre-eclampsia and eclampsia occurring in 15%–50% of pregnancies after high-risk pregnancies. High risk pregnancies are defined as those with multiple risk factors. High risk pregnancies are those with factors associated with increased severity and complications of preterm labour. Some risk factors are known and others are unknown. These include nulliparous and pre-eclamptic mothers, gestational diabetes and older maternal age (> 35 years). The risks of perinatal mortality and morbidity are increased with these and other factors. High risk pregnancies are of interest to parents and clinicians in terms of their impact on the lives of their families and children.

Unverified Answer

What are common treatments for high risk pregnancies?

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While it is commonly recommended during prenatal care that fetuses be screened for Down syndrome once a woman is found to be expecting a child, there is no conclusive evidence to suggest that women should be screened once they are found to be pregnant. Low-risk fetuses may be screened to determine pregnancy termination.

Unverified Answer

What does treatment usually treat?

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Incomplete treatment is the major contributor to adverse neurodevelopmental outcomes in RDS. The need to improve treatment algorithms and define treatment targets has to receive more attention in order to improve the neurodevelopmental outcomes of these children.

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Does high risk pregnancies run in families?

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[We find no evidence to support the popular perception that women with risk factors present a higher or a higher risk for delivering babies with major defects than the average. It is possible that the observed trend in these populations may reflect changes in the health-care system. We hypothesize, instead, that more rigorous and comprehensive screening is necessary before birth!

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Have there been other clinical trials involving treatment?

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There has been no randomized controlled trial testing the effectiveness of other treatment modalities compared with placebo in patients with advanced cancer. However, a few retrospective observational studies have suggested a benefit to the use of palliative treatment modalities, namely chemotherapy and photodynamic therapy, in advanced HCC in selected patients. In addition, there are a few open, uncontrolled or uncontrolled studies that demonstrate that some treatments for HCC, including chemotherapy and tyrosine kinase inhibitors, may be beneficial to patients with HCC. Clinical trials are urgently needed to confirm these preliminary data.

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What is treatment?

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Pregnancies with pregravid women and women aged 34 or older should receive the full scope of prenatal care and treatment, including a timely recognition of pre- eclampsia and timely delivery to a specialty hospital.

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Is treatment typically used in combination with any other treatments?

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There is no clear evidence that standard care is used in combination with other treatments. However, given this the possible adverse consequences of combined care, and high quality-of-life data from patients from all treatment groups suggests possible combinations that are better than one component treatment alone.

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Has treatment proven to be more effective than a placebo?

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Compared with a placebo, treatment given to high-risk pregnant women with a history of GDM is associated with less risk for subsequent development of T2D, higher risk for development of pre-eclampsia, lower risk for macrosomia, and higher risk for gestational diabetes mellitus. However, in the long term, it is not yet possible to draw definite conclusions regarding the best treatment approach for pregnant women presenting with a history of GDM. For example, treatment with metformin was not associated with increased risk of subsequent development of pre-eclampsia or macrosomia. More research is needed in this area before definitive recommendations can be made.

Unverified Answer
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