CLINICAL TRIAL

Decision Aid for High Risk Pregnancies

High Risk
Waitlist Available · < 65 · Female · Houston, TX

This study is evaluating whether a multimedia based educational tool and regular reminders with shared decision-making will increase the rate of long-acting reversible contraception (LARC) uptake and retention in high risk pregnancy patients within 12 weeks of delivery and to study the rates

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About the trial for High Risk Pregnancies

Eligible Conditions
High Risk Pregnancies · Contraception

Treatment Groups

This trial involves 2 different treatments. Decision Aid is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Decision Aid
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Routine Care
BEHAVIORAL

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Decision Aid
2008
Completed Phase 3
~4150

Eligibility

This trial is for female patients aged 65 and younger. There are 2 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Aged 13-50 years old
High risk pregnancy due to either maternal medical conditions or obstetric/neonatal complications
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 24 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 24 months.
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Decision Aid will improve 1 primary outcome and 2 secondary outcomes in patients with High Risk Pregnancies. Measurement will happen over the course of 12 weeks postpartum (12 weeks).

Rate of initial LARC utilization
12 WEEKS POSTPARTUM (12 WEEKS)
Number of subjects who elect to have LARC procedure between the 2 arms
12 WEEKS POSTPARTUM (12 WEEKS)
Number of patients who keep the LARC after placement
24 MONTHS
24 MONTHS
rates of short interval pregnancy
24 MONTHS
Number of patients who become pregnant after enrollment pregnancy
24 MONTHS

Who is running the study

Principal Investigator
E. J. Q.
Emma Jean Qureshey, Clinical MFM Fellow
The University of Texas Health Science Center, Houston

Patient Q & A Section

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

What is the primary cause of contraception?

Onset of sexual intercourse in the study population was at an average of 15.5 years of age, with [a maximum and average of 17.8 years (18.0 years] and 17.8 years [17.8 years], respectively, and averaging at 17.5 years (18.1 years) on average].

Anonymous Patient Answer

What are common treatments for contraception?

Treatment for contraception depends on the specifics of the contraception. For example, for sterilization, the options are surgical sterilization and tubal ligation. In addition, for fertility treatment, options include in vitro fertilization, intrauterine insemination (IUI), and oocyte donation. Common options include hormone replacement therapy (HRT), gonadotropin releasing hormone (GnRH) agonists, progestins, progestin/progesterone combination, combined oral contraceptive, transdermal estradiol patches, intrauterine contraceptive devices (IUDs), and cervical cap devices.

Anonymous Patient Answer

What causes contraception?

Although there is no specific definition of contraceptive withdrawal and the term 'contraception' may refer to a range of methods, we recommend that the term 'contraception' only be used when the reason for contraception discontinuation (not necessarily the method used) has been clearly and thoroughly documented.

Anonymous Patient Answer

What is contraception?

Contraception refers to sex management, and is used to prevent unintended pregnancies and the transmission of sexually transmitted infections. It is used in various ways including the use of birth control pills, rings, condoms, intrauterine devices, sponges, spermicide spray, diaphragms, vaginal rings, sterilization, sperm or egg retrieval or surgery. Contraception also refers to the act of using contraception. In the USA, less than 25% of sexually active women used birth control. Reasons for this discrepancy include lack of demand, fear of side effects, and not being sexually informed about the options.

Anonymous Patient Answer

Can contraception be cured?

There is no cure for chronic pelvic pain. Effective contraception can be provided to patients. However, patients are usually poorly informed as to the treatment options, especially when not provided at the time of medical consultation. As a result many patients suffer long-term pelvic pain and other complications despite the use of effective contraception.

Anonymous Patient Answer

What are the signs of contraception?

Women who have a regular menstrual cycle, and who have never taken the birth control pill, may be at an increased risk for pelvic inflammatory disease (PID), an inflammation of the lining of the uterus, an infection that is often associated with an unsafe abortion. These women might benefit from periodic pelvic ultrasounds to detect possible PID. Other signs and symptoms of PID include pelvic pain, a red uterus, lower abdominal pains or discomfort or, in severe cases, bleeding due to rupture of the uterine lining.

Anonymous Patient Answer

How many people get contraception a year in the United States?

Contrary to some expectations, the prevalence of contraceptive use was higher for foreign-born and foreign-born persons in the United States than for U.S.-born persons, suggesting that in this country, immigration alone does not affect fertility; however, it may be less important than the effect of gender and education.

Anonymous Patient Answer

Does decision aid improve quality of life for those with contraception?

Decision aids increased clinicians' understanding of potential harms and benefits of contraceptives before provision but did not improve contraceptive use. Further research is required to develop a more effective approach to achieving contraceptive choices.

Anonymous Patient Answer

How serious can contraception be?

It is apparent that these drugs can make women feel unwell. One is being prescribed for a minor complaint such as a skin rash. So, when considering the use of contraceptives for non-medical reasons, it is essential that women understand the risks and benefits of these drugs. Consult with your doctor before taking these drugs.

Anonymous Patient Answer

How does decision aid work?

A combination of information on contraceptives options, the option to choose a contraceptive method directly after the medical consultation and pre-assessment are helpful to ensure the informed choice for a pill taken for long-term use. Overall, all three types of information could improve the contraceptive method choice. Future work should focus on different contraceptive strategies and investigate the influence on women's intention and behavior.

Anonymous Patient Answer

What is the average age someone gets contraception?

The average age of someone getting contraception is 30 years old. The age where a woman's first period arrived is 24.9 years old for the average American.\n

Anonymous Patient Answer

Is decision aid safe for people?

The majority of women were satisfied with and interpreted their decision adequately. Most women believed that the decision aid made the decision easier and made better decisions.

Anonymous Patient Answer
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