Children Whose Mothers Received 17P and Those Who Received Vehicle in the 17P Efficacy TrialNCT01146990
A Prospective, Noninterventional Follow-Up Study of Children Aged 23 to 25 Months, Born to Mothers Who Received Hydroxyprogesterone Caproate Injection, 250 mg/mL, or Vehicle for Prevention of Preterm Birth
An observational study of Children Whose Mothers Received 17P and Those Who Received Vehicle in the 17P Efficacy Trial, run by AMAG Pharmaceuticals, Inc. at 40 sites in 7 countries.
Trial summary
In the continuing efforts to understand the benefits and risks of in utero exposure to 17P this study is designed to evaluate differences in developmental outcomes of children, aged 23 to 25 months, born to mothers who participated in the 17P Efficacy Trial sponsored by Hologic (Protocol number 17P-ES-003). Read more about this study
- Who is it for?
- Ages 22 to 25 months
- Conditions the study is for
- Children Whose Mothers Received 17P and Those Who Received Vehicle in the 17P Efficacy Trial
- What is being tested?
- ASQ-3, Bayley III, Neurologic exam
- How many people
- 245 participants
- Where
- 40 sitesin 7 countries
- Study dates
- 9 Nov 2010to 13 Aug 2020
- Phase
- Observational
- 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 22 to 25 months
- All sexes
- No healthy volunteers
- Child
Study population: Children whose mothers received 17P and those who received vehicle in the 17P Efficacy Trial
Who may be able to join
- 1. Maternal enrollment which resulted in a live birth in the 17P Efficacy Trial: A Multi-center, Randomized, Double-blind Study of Hydroxyprogesterone Caproate Injection, 250 mg/mL, Versus Vehicle for the Prevention of Preterm Birth in Women With a Previous Singleton Spontaneous Preterm Delivery.
- 2. During their involvement in the above protocol, mothers must have received at least one dose of study drug (Safety population).
- 3. Children between 22 and 25 months of age adjusted for gestational age.
Who cannot join
- 1. There is no parent/legal guardian available to sign an informed consent. 2. Born to women who are unblinded to study group assignment.
Trial locations and contacts
40 sites in 7 countries.
40 sites in 7 countries
United States24 sites
Steven Z Lenowitz, MD, LLC
Bel Air, Maryland, 21014
The Women's Clinic
Boise, Idaho, 83712
Women's Associates
Colorado Springs, Colorado, 80903
SC Clinical Research Center, LLC
Columbia, South Carolina, 29201
Practice Research Organization, Inc.
Dallas, Texas, 75320
Tripler Army Medical Center
Honolulu, Hawaii, 96859
Women's Healthcare Associates dba Rosemark WomenCare Specialists
Idaho Falls, Idaho, 83404
Grossmont Center for Clinical Research
La Mesa, California, 91942
Wilford Hall Medical Center
Lackland Air Force Base, Texas, 78236
Tanner Clinic
Layton, Utah, 84041
University of Louisville School of Medicine
Louisville, Kentucky, 40202
Women's Care Physicians/Obstetrical Specialists, PLLC
Louisville, Kentucky, 40207
Women's Physician Group
Memphis, Tennessee, 38104
Drug Research Analysis Corp
Montgomery, Alabama, 36106
Central Utah Clinic, Division of Mt. Timpanogos Women's Health Care
Pleasant Grove, Utah, 84062
Naval Medical Center
Portsmouth, Virginia, 23708
Saginaw Valley Medical Research Group, LLC/Women's OB GYN, PC
Saginaw, Michigan, 48604
Naval Medical Center San Diego
San Diego, California, 92124
Salt Lake Women's Center, PC
Sandy City, Utah, 84070
Washington University School of Medicine
St Louis, Missouri, 63110
Madigan Army Medical Center
Tacoma, Washington, 98431
Watching Over Mothers and Babies Foundation
Tucson, Arizona, 85712
Lyndhurst Gynecologic Associates
Winston-Salem, North Carolina, 27103
Triad Research Partners, LLC
Winston-Salem, North Carolina, 27103
Hungary4 sites
Debreceni Egyetem Orvos és Egészségtudományi Centrum, Szülészeti és Nogyógyászati Klinika
Debrecen, Hajdú-Bihar, 4032
Petz Aladár Megyei Oktató Kórház
Győr, Győr-Moson-Sopron, 9023
Jósa András Oktatókórház Egészségügyi Szolgáltató Nonprofit Kft.
Nyíregyháza, Szabolcs-Szatmár-Bereg, 4400
Szegedi Tudományegyetem Szülészeti és Nogyógyászati Klinika
Szeged, Csongrád megye, 6725
Spain4 sites
Hospital Vall d'Hebrón
Barcelona, 08035
Hospital Universitario Puerta Del Mar
Cadiz, 11009
Hospital Universitario Materno Infantil de Canarias
Las Palmas de Gran Canaria, 35016
Hospital Universitario La Fe, Servicio de Neonatologia
Valencia, 46009
Russia3 sites
Kazan State Medical University
Kazan', 420012
Krasnoyarsk State Medical University named after Prof. V.F.Voino-Yasenetsky
Krasnoyarsk, 660100
State Educational Institution Saint Petersburg I.I. Mechnikov State Medical Academy of RosZdrav
Saint Petersburg, 195257
Canada2 sites
The Ottawa Hospital
Ottawa, Ontario, K1H8L6
Medicine Professional Corporation Obstetrics and Gynaecology
Windsor, Ontario, N8X 3V6
Czechia2 sites
Fakultni nemocnice Hradec Králové
Hradec Králové, 50005
Fakultní Nemocnice Ostrava
Ostrava, 708 52
Ukraine1 site
Institute of Pediatrics, Obstetrics and Gynecology of the Academy of Medical Sciences of Ukraine
Kiev, 02050
About this study
In the continuing efforts to understand the benefits and risks of in utero exposure to 17P this study is designed to evaluate differences in developmental outcomes of children, aged 23 to 25 months, born to mothers who participated in the 17P Efficacy Trial sponsored by Hologic (Protocol number 17P-ES-003).
Read the detailed description
This will be a prospective, noninterventional follow-up study designed to provide a developmental assessment of children born to mothers who participated in the 17P Efficacy Trial. When subjects reach an age of 23 months after adjustment for gestational age, they will be screened for developmental delay using the 24 month ASQ version 3. Subjects who score positive (fall below the specified cut-off) for developmental delay in 1 or more domains will be referred for the 24 month Bayley Scales of Infant and Toddler Development (3rd edition, Bayley-III) and a neurological examination.
- Conditions
- Children Whose Mothers Received 17P and Those Who Received Vehicle in the 17P Efficacy Trial
- Being tested
- ASQ-3, Bayley III, Neurologic exam
- Keywords
- 17P Efficacy Trial Follow up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASQ-3, Bayley III, Neurologic examDrug
Developmental Scales of infant development - Children born to mothers who participated in the 17P-ES-003 study will be enrolled in this study and evaluated using the ASQ-3. Those meeting protocol criteria based on ASQ-3, will be evaluated using the Bayley III and have a neurologic examination.
| Study group | Role | What they receive |
|---|---|---|
| Infants Born to Mothers in the 17P-ES-003 Study | Infants Born to Mothers Who Participated in the 17P-ES-003 Study and whose mothers consented for them to be followed for this study. Receives: Drug: ASQ-3, Bayley III, Neurologic exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine whether there is a difference in developmental status between children whose mothers received 17P and those who received vehicle in the 17P Efficacy Trial
The primary objective of this study is to determine whether there is a difference in developmental status between children, aged 23 to 25 months after adjustment for gestational age, whose mothers received 17P and those who received vehicle in the 17P Efficacy Trial.
Measured: aged 23 to 25 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study start9 Nov 2010
- Primary completion13 Aug 2020
- Study completion13 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children Whose Mothers Received 17P and Those Who Received Vehicle in the 17P Efficacy TrialStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- AMAG Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Registrat-Mapi
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01146990
- Sponsor's protocol ID
- 17P-FU-004
- Status last verified
- May 2022
- First submitted
- 16 Jun 2010
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Noninterventional Follow-Up Study of Children Aged 23 to 25 Months, Born to Mothers Who Received Hydroxyprogesterone Caproate Injection, 250 mg/mL, or Vehicle for Prevention of Preterm Birth
- ClinicalTrials.gov ID
- NCT01146990
- Acronym / sponsor ID
- 17P-FU-004
- Conditions
- Children Whose Mothers Received 17P and Those Who Received Vehicle in the 17P Efficacy Trial
- Keywords
- 17P Efficacy Trial Follow up
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- AMAG Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Registrat-Mapi
- Study start
- 9 Nov 2010 (actual)
- Primary completion
- 13 Aug 2020 (actual)
- Study completion
- 13 Aug 2020 (actual)
- First posted
- 22 Jun 2010 (estimated)
- 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.
In the continuing efforts to understand the benefits and risks of in utero exposure to 17P this study is designed to evaluate differences in developmental outcomes of children, aged 23 to 25 months, born to mothers who participated in the 17P Efficacy Trial sponsored by Hologic (Protocol number 17P-ES-003).
Detailed description
This will be a prospective, noninterventional follow-up study designed to provide a developmental assessment of children born to mothers who participated in the 17P Efficacy Trial. When subjects reach an age of 23 months after adjustment for gestational age, they will be screened for developmental delay using the 24 month ASQ version 3. Subjects who score positive (fall below the specified cut-off) for developmental delay in 1 or more domains will be referred for the 24 month Bayley Scales of Infant and Toddler Development (3rd edition, Bayley-III) and a neurological examination.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infants Born to Mothers in the 17P-ES-003 Study | – | Drug: ASQ-3, Bayley III, Neurologic examInfants Born to Mothers Who Participated in the 17P-ES-003 Study and whose mothers consented for them to be followed for this study. |
Who may qualify
- Ages
- 22 to 25 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children whose mothers received 17P and those who received vehicle in the 17P Efficacy Trial
Key inclusion criteria (3 listed)
- 1. Maternal enrollment which resulted in a live birth in the 17P Efficacy Trial: A Multi-center, Randomized, Double-blind Study of Hydroxyprogesterone Caproate Injection, 250 mg/mL, Versus Vehicle for the Prevention of Preterm Birth in Women With a Previous Singleton Spontaneous Preterm Delivery.
- 2. During their involvement in the above protocol, mothers must have received at least one dose of study drug (Safety population).
- 3. Children between 22 and 25 months of age adjusted for gestational age.
Key exclusion criteria (1 listed)
- 1. There is no parent/legal guardian available to sign an informed consent. 2. Born to women who are unblinded to study group assignment.
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 |
|---|---|---|
| ASQ-3, Bayley III, Neurologic examDevelopmental Scales of infant development - Children born to mothers who participated in the 17P-ES-003 study will be enrolled in this study and evaluated using the ASQ-3. Those meeting protocol criteria based on ASQ-3, will be evaluated using the Bayley III and have a neurologic examination. | Drug | Infants Born to Mothers in the 17P-ES-003 Study |
Primary outcome
Determine whether there is a difference in developmental status between children whose mothers received 17P and those who received vehicle in the 17P Efficacy Trial
Time frame: aged 23 to 25 months
The primary objective of this study is to determine whether there is a difference in developmental status between children, aged 23 to 25 months after adjustment for gestational age, whose mothers received 17P and those who received vehicle in the 17P Efficacy Trial.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
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.
40 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Children Whose Mothers Received 17P and Those Who Received Vehicle in the 17P Efficacy Trial, run by AMAG Pharmaceuticals, Inc. at 40 sites in 7 countries.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, Hungary, Spain, Russia, Canada and 2 more countries. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determine whether there is a difference in developmental status between children whose mothers received 17P and those who received vehicle in the 17P Efficacy Trial (time frame: aged 23 to 25 months). 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 18 May 2022.