Pregnancy RelatedDAWNNCT04052347
Decision Aid to Assist Low-Risk Nulliparous Women Considering Induction of Labor At 39 Weeks
A study testing Shared decision-making with a Decision-aid and routine shared decision-making in people with Pregnancy Related and Elective Induction, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The primary objective is to assess if the utilization of a decision-aid increases the likelihood of low-risk nulliparous women undergoing elective induction of labor at 39.0-39.6 weeks Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Elective Induction
- What is being tested?
- Shared decision-making with a Decision-aid and routine shared decision-making
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2019to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Low-risk nulliparous women- no previous pregnancy > 23 weeks
- 18-50 years of age
- Singleton gestation
- Between 34.0 and 36.6 weeks at the time of screening. Randomization must occur between 37.0-37.6 weeks inclusive.
Who cannot join
- 1. First sonographic examination after 20 weeks 2. Women with any of the following comorbidities (at the time of randomization):
- Autoimmune disorders (antiphospholipid antibody, lupus, rheumatoid arthritis, scleroderma)
- Cerclage in the index pregnancy
- Diabetes mellitus-gestational or pre-gestational
- Hematologic disorders (coagulation defects, sickle cell disease, thrombocytopenia, thrombophilia)
- Hypertension (chronic or pregnancy induced) before enrollment
Show all 18Show fewer
- HIV (human immunodeficiency virus)
- Institutionalized individuals (prisoners)
- Prior obstetric history of: 1) intrauterine growth restriction, 2) preterm birth before 34 weeks, 3) severe preeclampsia, eclampsia, HELLP syndrome, and 4) stillbirth after 24 weeks or neonatal death
- Preterm labor or ruptured membranes before enrollment
- Psychiatric disorder (bipolar, depression) on medication
- Placenta previa / 3rd trimester bleeding
- Renal insufficiency (serum creatinine > 1.5 mg/dL)
- Restrictive lung disease
- Fetal red blood cell isoimmunization
- Seizure disorder on medication
- Thyroid disease on medication
- Body Mass Index (BMI) above 40 kg/m 3. Major fetal Anomaly including: anencephaly, spina bifida, bilateral renal agenesis, cystic hygroma with hydrops, diaphragmatic hernia, or congenital heart defects 4. Unable to understand consent in English or Spanish
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Decision Aid to Assist Low-Risk Nulliparous Women Considering Induction of Labor At 39 Weeks: A Randomized Trial (DAWN Trial)
The primary objective is to assess if the utilization of a decision-aid increases the likelihood of low-risk nulliparous women undergoing elective induction of labor at 39.0-39.6 weeks
- Conditions
- Pregnancy Related, Elective Induction
- Being tested
- Shared decision-making with a Decision-aid, routine shared decision-making
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared decision-making with a Decision-aidBehavioural
A tablet computer-based decision-aid was developed by the study investigators based on the standards of the International Patient Decision Aid Standards Collaboration9
routine shared decision-makingBehavioural
control group
| Study group | Role | What they receive |
|---|---|---|
| Shared decision-making with a patient decision-aid | Experimental | Not described Receives: Behavioral: Shared decision-making with a Decision-aid |
| routine shared decision-making | Active comparator | control group Receives: Behavioral: routine shared decision-making |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects who decided to undergo elective induction of labor at 39.0-39.6 weeks after utilization of a decision-aid
Number of subjects who decided to undergo elective induction of labor at 39.0-39.6 weeks after utilization of a decision-aid
Measured: 4 weeks
Secondary outcomes (2)
Composite neonatal morbidity
Composite neonatal morbidity among (CNM) is any of the following: 1) Apgar score < 7 at 5 min, 2) umbilical arterial pH < 7.00, 3) intraventricular hemorrhage grade III or IV, 4) periventricular leukomalacia, 5) intubation for over 24 hrs, 6) necrotizing enterocolitis grade 2 or 3, 7) stillbirth or 8) death within 28 days of birth.
Measured: at delivery
Maternal morbidities
Number of subjects with morbidities as described by American College of Obstetrics and Gynecology (ACOG)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start25 Nov 2019
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Why it stopped: Covid related
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sunbola S Ashimi Ademola, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04052347
- Sponsor's protocol ID
- HSC-MS-19-0490
- Acronym
- DAWN
- Status last verified
- Feb 2021
- First submitted
- 15 Jul 2019
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decision Aid to Assist Low-Risk Nulliparous Women Considering Induction of Labor At 39 Weeks: A Randomized Trial (DAWN Trial)
- ClinicalTrials.gov ID
- NCT04052347
- Acronym / sponsor ID
- DAWN / HSC-MS-19-0490
- Conditions
- Pregnancy Related, Elective Induction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Covid related
- Enrolment
- 2 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 9 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to assess if the utilization of a decision-aid increases the likelihood of low-risk nulliparous women undergoing elective induction of labor at 39.0-39.6 weeks
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shared decision-making with a patient decision-aid | Experimental | Behavioral: Shared decision-making with a Decision-aid |
| routine shared decision-making | Active comparator | Behavioral: routine shared decision-makingcontrol group |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Low-risk nulliparous women- no previous pregnancy > 23 weeks
- 18-50 years of age
- Singleton gestation
- Between 34.0 and 36.6 weeks at the time of screening. Randomization must occur between 37.0-37.6 weeks inclusive.
Key exclusion criteria (18 listed)
- 1. First sonographic examination after 20 weeks 2. Women with any of the following comorbidities (at the time of randomization):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shared decision-making with a Decision-aidA tablet computer-based decision-aid was developed by the study investigators based on the standards of the International Patient Decision Aid Standards Collaboration9 | Behavioural | Shared decision-making with a patient decision-aid |
| routine shared decision-makingcontrol group | Behavioural | routine shared decision-making |
Primary outcome
Number of subjects who decided to undergo elective induction of labor at 39.0-39.6 weeks after utilization of a decision-aid
Time frame: 4 weeks
Number of subjects who decided to undergo elective induction of labor at 39.0-39.6 weeks after utilization of a decision-aid
2 secondary outcomes
Composite neonatal morbidity
Time frame: at delivery
Maternal morbidities
Time frame: 1 week
Results and safety
The study was stopped early (reason given: Covid related). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shared decision-making with a Decision-aid and routine shared decision-making in people with Pregnancy Related and Elective Induction, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Covid related). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects who decided to undergo elective induction of labor at 39.0-39.6 weeks after utilization of a decision-aid (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.