Family Planning Ahead

January 7, 2019 updated by: Rachel L. Thompson, Dartmouth-Hitchcock Medical Center
Family Planning Ahead is a study that aims to improve decision-making about postpartum contraception. Family Planning Ahead will test two different strategies: a patient decision aid and a patient information leaflet.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
41

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Internet (Dartmouth College)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Currently pregnant
  • Between 28 and 38 weeks' gestation at the time of enrollment
  • Estimated due date in March, April, May, or June 2018
  • 15 years or older
  • Can read and write English
  • Live in the United States
  • Share a valid email address for study purposes

Exclusion Criteria

  • Not currently pregnant
  • Less than 28 weeks' or more than 38 weeks' gestation at the time of enrollment
  • Estimated due date earlier than March 2018 or later than June 2018
  • Under 15 years
  • Can not read and write English
  • Do not live in the United States
  • Do not share a valid email address for study purposes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Patient Decision Aid
Birth Control After Pregnancy patient decision aid and supporting document
Other: Birth Control After Pregnancy
A 27-page patient decision aid in portable document format (and an accompanying 3-page supporting document in portable document format) hosted online.
Active Comparator: Patient Information Leaflet
Postpartum Birth Control patient information leaflet
Other: Postpartum Birth Control
A 4-page patient information leaflet in portable document format and text format hosted online.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Perceived support in decision-making
Time Frame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
The extent to which the person feels they received adequate support and advice without pressure to make a decision about postpartum contraceptive methods, measured using adapted versions of the Support subscale of the Decisional Conflict Scale (O'Connor, 1993).
T2 (Approximately 7-11 weeks after self-reported estimated due date)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Perceptions of being informed
Time Frame: T0 (immediately following study enrollment); T1 (one week following study enrollment)
The extent to which the person feels informed of available postpartum contraceptive methods and the benefits, risks, and side effects of each, measured using an adapted version of the Informed subscale of the Decisional Conflict Scale (O'Connor, 1993).
T0 (immediately following study enrollment); T1 (one week following study enrollment)
Values clarity
Time Frame: T0 (immediately following study enrollment); T1 (one week following study enrollment)
The extent to which the person feels clear about personal values related to postpartum contraceptive method benefits, risks, and side effects, measured using an adapted version of the Values Clarity subscale of the Decisional Conflict Scale (O'Connor, 1993).
T0 (immediately following study enrollment); T1 (one week following study enrollment)
Decisional uncertainty
Time Frame: T0 (immediately following study enrollment); T1 (one week following study enrollment)
The extent to which the person feels certain about which postpartum contraceptive method to choose, measured using an adapted version of the Uncertainty subscale of the Decisional Conflict Scale (O'Connor, 1993).
T0 (immediately following study enrollment); T1 (one week following study enrollment)
Decision self-efficacy
Time Frame: T0 (immediately following study enrollment); T1 (one week following study enrollment)
The extent to which the person has self-confidence or belief in their ability to make decisions about postpartum contraceptive methods, measured using an adapted version of the Decision Self-Efficacy Scale (O'Connor, 1995).
T0 (immediately following study enrollment); T1 (one week following study enrollment)
Intended contraceptive method(s): LARC vs. other
Time Frame: T0 (immediately following study enrollment); T1 (one week following study enrollment)
The proportion of people who intend to use a long-acting reversible contraceptive (LARC) method (i.e., hormonal intrauterine device, copper intrauterine device, or implant) 'in the first few months after giving birth', measured using a self-developed item.
T0 (immediately following study enrollment); T1 (one week following study enrollment)
Intended contraceptive method(s): Most or moderately effective vs. other
Time Frame: T0 (immediately following study enrollment); T1 (one week following study enrollment)
The proportion of people who intend to use a most or moderately effective contraceptive method (i.e., female sterilization, hormonal intrauterine device, copper intrauterine device, implant, injection, combined pill, progestin-only pill, patch, ring, diaphragm) 'in the first few months after giving birth', measured using a self-developed item.
T0 (immediately following study enrollment); T1 (one week following study enrollment)
Intended contraceptive method(s): Method vs. no method or unsure
Time Frame: T0 (immediately following study enrollment); T1 (one week following study enrollment)
The proportion of people who intend to use one or more contraceptive methods (i.e., female sterilization, hormonal intrauterine device, copper intrauterine device, implant, injection, combined pill, progestin-only pill, patch, ring, diaphragm, male condom, internal (female) condom, spermicide, sponge, cervical cap, lactational amenorrhea method, withdrawal, fertility awareness, male sterilization, and/or emergency contraceptive pill) 'in the first few months after giving birth', measured using a self-developed item.
T0 (immediately following study enrollment); T1 (one week following study enrollment)
Intended timing of contraceptive method(s) initiation: Not unsure vs. unsure
Time Frame: T0 (immediately following study enrollment); T1 (one week following study enrollment)
The proportion of people who are not unsure about how soon after giving birth they will (first) start using a contraceptive method (i.e., intend to start using a contraceptive method 'in the first 10 minutes', 'in the first few days', 'in the first few weeks', 'around 6 weeks', 'in the first few months' or 'other'), measured using a self-developed item.
T0 (immediately following study enrollment); T1 (one week following study enrollment)
Values concordance of intended contraceptive method(s)
Time Frame: T0 (immediately following study enrollment); T1 (one week following study enrollment)
The proportion of people who perceive optimal values concordance of their intended postpartum contraceptive method(s) (or intention to use no contraceptive methods), measured using the Measure of Alignment of Choices (Thompson et al., 2017).
T0 (immediately following study enrollment); T1 (one week following study enrollment)
Trust in health professional(s)
Time Frame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
The extent to which the person feels trust in the health professional(s) they talk to about postpartum contraception during and/or after pregnancy, measured using an adapted version of the Patient Trust in a Physician Scale (Dugan et al., 2005).
T2 (Approximately 7-11 weeks after self-reported estimated due date)
Interpersonal quality of family planning care
Time Frame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
The proportion of people who report high interpersonal quality of family planning care during and/or after pregnancy, measured using an adapted version of the four-item Interpersonal Quality of Family Planning Care (IQFP-R) scale (Dehlendorf et al. 2016).
T2 (Approximately 7-11 weeks after self-reported estimated due date)
Shared decision-making
Time Frame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
The extent to which which the person feels they experienced shared decision-making about postpartum contraceptive methods during and/or after pregnancy, measured using the CollaboRATE measure (Barr et al., 2014).
T2 (Approximately 7-11 weeks after self-reported estimated due date)
Concordance between preferred and actual decision-making involvement (self): Concordant vs. discordant
Time Frame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
The proportion of people who report concordance between their actual and preferred involvement in the decision to use their postpartum contraceptive method(s), measured using two self-developed items.
T2 (Approximately 7-11 weeks after self-reported estimated due date)
Concordance between preferred and actual decision-making involvement (partner): Concordant vs. discordant
Time Frame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
The proportion of people who report concordance between the actual involvement of their partner and their preferences pertaining to partner involvement in the decision to use their postpartum contraceptive method(s), measured using two self-developed items.
T2 (Approximately 7-11 weeks after self-reported estimated due date)
Concordance between preferred and actual decision-making involvement (health professional(s)): Concordant vs. discordant
Time Frame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
The proportion of people who report concordance between the actual involvement of their health professional(s) and their preferences pertaining to health professional involvement in the decision to use their postpartum contraceptive method(s), measured using two self-developed items.
T2 (Approximately 7-11 weeks after self-reported estimated due date)
Time pressure in decision-making
Time Frame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
The extent to which the person feels they had (or have) enough time to make a decision about postpartum contraceptive methods, measured using a self-developed item.
T2 (Approximately 7-11 weeks after self-reported estimated due date)
Pressure to use a certain contraceptive method
Time Frame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
The extent to which the person felt (or feels) pushed to use a certain postpartum contraceptive method, measured using a self-developed item.
T2 (Approximately 7-11 weeks after self-reported estimated due date)
Values concordance of contraceptive method(s) used
Time Frame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
The proportion of people who perceive optimal values concordance of the postpartum contraceptive method(s) they have used, measured using the Measure of Alignment of Choices (Thompson et al., 2017).
T2 (Approximately 7-11 weeks after self-reported estimated due date)
Effective decision
Time Frame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
The extent to which the person feels they made an effective decision about postpartum contraceptive methods, measured using an adapted version of the Effective Decision subscale of the Decisional Conflict Scale (O'Connor, 1993).
T2 (Approximately 7-11 weeks after self-reported estimated due date)
Contraceptive method(s) prescribed in first 60 days: LARC vs. other
Time Frame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
The proportion of people who report being given or prescribed a long-acting reversible contraceptive (LARC) method (i.e., hormonal intrauterine device, copper intrauterine device, or implant) in the first 60 days after giving birth, measured using a self-developed item.
T2 (Approximately 7-11 weeks after self-reported estimated due date)
Contraceptive method(s) prescribed in first 60 days: Most or moderately effective vs. other
Time Frame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
The proportion of people who report being given or prescribed a most or moderately effective contraceptive method (i.e., female sterilization, hormonal intrauterine device, copper intrauterine device, implant, injection, combined pill, progestin-only pill, patch, ring, diaphragm) in the first 60 days after giving birth, measured using a self-developed item.
T2 (Approximately 7-11 weeks after self-reported estimated due date)
Contraceptive method(s) prescribed in first 3 days: LARC vs. other
Time Frame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
The proportion of people who report being given or prescribed a long-acting reversible contraceptive (LARC) method (i.e., hormonal intrauterine device, copper intrauterine device, or implant) in the first 3 days after giving birth, measured using a self-developed item.
T2 (Approximately 7-11 weeks after self-reported estimated due date)
Contraceptive method(s) prescribed in first 3 days: Most or moderately effective vs. other
Time Frame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
The proportion of people who report being given or prescribed a most or moderately effective contraceptive method (i.e., female sterilization, hormonal intrauterine device, copper intrauterine device, implant, injection, combined pill, progestin-only pill, patch, ring, diaphragm) in the first 3 days after giving birth, measured using a self-developed item.
T2 (Approximately 7-11 weeks after self-reported estimated due date)
Contraceptive method(s) used: LARC vs. other
Time Frame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
The proportion of people who, at the time of survey completion, report having used a long-acting reversible contraceptive (LARC) method (i.e., hormonal intrauterine device, copper intrauterine device, or implant) since giving birth, measured using a self-developed item.
T2 (Approximately 7-11 weeks after self-reported estimated due date)
Contraceptive method(s) used: Most or moderately effective vs. other
Time Frame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
The proportion of people who, at the time of survey completion, report having used a most or moderately effective contraceptive method (i.e., female sterilization, hormonal intrauterine device, copper intrauterine device, implant, injection, combined pill, progestin-only pill, patch, ring, diaphragm) since giving birth, measured using a self-developed item.
T2 (Approximately 7-11 weeks after self-reported estimated due date)
Contraceptive method(s) used: Method vs. no method
Time Frame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
The proportion of people who, at the time of survey completion, report having used one or more contraceptive methods (i.e., female sterilization, hormonal intrauterine device, copper intrauterine device, implant, injection, combined pill, progestin-only pill, patch, ring, diaphragm, male condom, internal (female) condom, spermicide, sponge, cervical cap, lactational amenorrhea method, withdrawal, fertility awareness, male sterilization, and/or emergency contraceptive pill) since giving birth, measured using a self-developed item.
T2 (Approximately 7-11 weeks after self-reported estimated due date)
Timing of decision about contraceptive method(s): During pregnancy vs. since giving birth
Time Frame: T2 (Approximately 7-11 weeks after self-reported estimated due date)
The proportion of people who report deciding to use their postpartum contraceptive method(s) during pregnancy, measured using a self-developed item.
T2 (Approximately 7-11 weeks after self-reported estimated due date)
Likelihood of recommending the intervention to a friend
Time Frame: T1 (one week following study enrollment)
The proportion of people who report that they are extremely likely to recommend the intervention to a friend, measured using a self-developed item.
T1 (one week following study enrollment)
Likelihood of reviewing the intervention in the future
Time Frame: T1 (one week following study enrollment)
The proportion of people who report that they are extremely likely to review the intervention in the future, measured using a self-developed item.
T1 (one week following study enrollment)
Perceived utility of the intervention
Time Frame: T1 (one week following study enrollment)
The extent to which the person perceives that the intervention was useful in preparing them to communicate with their health professional and make a decision, measured using an adapted version of the Preparation for Decision Making Scale (Graham & O'Connor, 2010).
T1 (one week following study enrollment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dartmouth-Hitchcock Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rachel Thompson, PhD, Dartmouth College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 22, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 23, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 23, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 18, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 9, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 00030871

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The investigators will make an anonymized copy of the final participant-level data set available to others for research purposes, either via data sharing on request or digital repository deposit.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings