Preterm BirthPhase 2/3170HPNCT00163020
17OHP for Reduction of Neonatal Morbidity Due to Preterm Birth (PTB) in Twin and Triplet Pregnancies
A Phase 2/3 study testing 17-alpha-hydroxyprogesterone caproate injectable in people with Preterm Birth, run by Obstetrix Medical Group at 18 sites in United States.
Trial summary
Hypothesis: Among women with twin or triplet pregnancies, weekly injections of 17-alpha-hydroxyprogesterone caproate (17OHP), started before 24 weeks of gestation, will reduce neonatal morbidity by reducing the rate of preterm delivery. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Preterm Birth
- What is being tested?
- 17-alpha-hydroxyprogesterone caproate injectable
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 321 participants
- Where
- 18 sitesUnited States
- Study dates
- Nov 2004to Aug 2009
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gestational age (GA) 15-23w0d gestational age at the time of recruitment
- GA 16w0dk to 23w6d at the time of randomization and initiation of injections
- Maternal age 18 years or older
- One of these risk factors for spontaneous preterm birth:
- Twins in current pregnancy, dichorionic placentation
- Triplets in current pregnancy, trichorionic placentation
Show all 9Show fewer
- Intact membranes
- Patient has had at least one detailed 2nd-trimester ultrasound examination documenting placentation, chorionicity, fetal number, fetal size, amniotic fluid volumes, and fetal anatomy. (This examination must comply with minimum standards such as those published by the American Institute of Ultrasound in Medicine, American College of Radiology, or American College of Obstetricians \& Gynecologists It is NOT mandatory that this examination be performed at the research-study center.)
- Investigator believes patient will be reliable with follow-up visits and believes that delivery data and neonatal data are likely to be available.
Who cannot join
- Symptomatic uterine contractions in current pregnancy
- Contraindication to interventions intended to prolong the pregnancy (including lethal fetal anomalies, amnionitis, preeclampsia, severe oligohydramnios, severe growth delay, fetal death appears imminent or inevitable)
- Risk factors for major neonatal morbidity unrelated to preterm delivery (such as monochorionic placentation in multiple gestation, major malformations, certain medication exposures)
- Preexisting maternal medical condition that might be worsened by progesterone therapy, including: asthma requiring medications, renal insufficiency, seizure disorder, ischemic heart disease, active cholecystitis, impaired liver function, history of thromboembolic disorder, history of breast cancer, history of major depression requiring hospitalization.
- Preexisting maternal medical condition associated with a high risk of preterm delivery including: refractory hypertension, diabetes with nephropathy or retinopathy, renal insufficiency, active systemic lupus erythematosus. Note that a history of prior preterm birth is NOT an exclusion.
- Use of progesterone or progesterone-derivative medication after 15 weeks gestation in current pregnancy.
- Allergy to 17OHP or oil vehicle.
- Placement of emergent cerclage (defined as one placed after the occurrence of cervical change such as dilation, funneling, or effacement) with this pregnancy. Prophylactic cerclage is NOT an exclusion (defined as one placed before any cervical change, for example, because of a history of cervical incompetence, or because of a prior cervical procedure such as LEEP or cone biopsy).
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Erlanger Medical Center
Chattanooga, Tennessee, 37403
Baylor University Medical Center
Dallas, Texas, 75246
Swedish Medical Center
Denver, Colorado, 80110
Presbyterian/St Luke's Hospital
Denver, Colorado, 80218
Rose Medical Center
Denver, Colorado, 80220
Mercy Medical Center
Des Moines, Iowa, 50314
Harris Methodist Fort Worth Hospital
Fort Worth, Texas, 76104
Saint Luke's Hospital, Kansas City
Kansas City, Missouri, 64111
Evergreen Hospital
Kirkland, Washington, 98034
Saddleback Memorial Medical Center
Laguna Hills, California, 92653
Skyridge Medical Center
Lonetree, Colorado, 80124
Long Beach Memorial Medical Center
Long Beach, California, 90801-1428
University of Southern California-Irvine Medical Center
Orange, California, 92868
Banner Good Samaritan Hospital
Phoenix, Arizona, 85006
Good Samaritan Hospital
San Jose, California, 95124
Swedish Medical Center
Seattle, Washington, 98122-4307
Tacoma General Hospital
Tacoma, Washington, 98405
Tucson Medical Center
Tucson, Arizona, 85712
About this study
Official title: 17-Alpha-Hydroxyprogesterone Caproate for Reduction of Neonatal Morbidity Due to Preterm Birth in Twin and Triplet Pregnancies - A Concurrent Randomized Double-blinded Clinical Trial
Hypothesis: Among women with twin or triplet pregnancies, weekly injections of 17-alpha-hydroxyprogesterone caproate (17OHP), started before 24 weeks of gestation, will reduce neonatal morbidity by reducing the rate of preterm delivery.
This study involves two concurrent double-blinded randomized clinical trials of 17OHP versus placebo. Each trial will test the efficacy and safety of 17OHP in women with a specific risk factor for preterm birth. The two risk factors to be studied are:
- Twin pregnancy
- Triplet pregnancy
Read the detailed description
Prematurity is a leading cause of neonatal morbidity and mortality in the USA. Nationally, 12% of all babies deliver before term and 3% deliver before 32 wks gestational age (GA). Recent studies suggest that 17OHP and other progesterone derivatives may reduce the rate of preterm birth among women with a history of prior preterm birth. However, it has not been demonstrated that this reduction in preterm birth is accompanied by a clinically significant reduction in neonatal complications. Further, most women who deliver preterm have no history of a prior preterm birth. Little is known about whether progesterone treatment is effective in women with other risk factors for preterm birth such as multiple gestation. The proposed study will assess the role of 17OHP in women with twin or triplet pregnancies and will assess the impact on neonatal health, not merely the impact on gestational age at delivery. Prior studies were not designed to be large enough to have statistical power to assess effects on neonatal morbidity.
In the 6 trials combined in the Goldstein meta-analysis, only 279 women were treated with 17OHP and only 73 women had a preterm delivery. The NICHD study presented by Meis approximately doubles the world-wide experience, with 306 women under treatment, of whom 73 delivered prior to 35 wks. Yet, this study was not designed to have power to show a reduction in neonatal complications but only a reduction in preterm birth rates.
The present study is the first to be specifically designed to have adequate power to test whether 17OHP reduces neonatal morbidity among women with one of two specific risk factors for preterm birth.
- Conditions
- Preterm Birth
- Being tested
- 17-alpha-hydroxyprogesterone caproate injectable, Placebo
- Keywords
- Preterm Birth, Preterm Delivery, Multiple gestation, 17-alpha-hydroxyprogesterone caproate, Progesterone
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
17-alpha-hydroxyprogesterone caproate injectableDrug
Also called 170HP
250mg of 17-alpha-hydroxyprogesterone caproate (+ preservatives) injectable weekly starting as early as 19wks gestation until 34.0wks gestation of delivery which ever comes first.
PlaceboDrug
Also called Normal Saline
Weekly doses of placebo (NS + preservatives) via injection as early as 19weeks until 34.0weeks gestation or delivery which ever comes first.
| Study group | Role | What they receive |
|---|---|---|
| 1 Test Group (170HP) | Active comparator | Test Group will receive weekly doses of 170HP via injection as early as 19weeks until 34.0weeks gestation or delivery which ever comes first. Receives: Drug: 17-alpha-hydroxyprogesterone caproate injectable |
| 2 - Control (Normal Saline) | Placebo comparator | Control Group will receive weekly doses of placebo (NS) via injection as early as 19weeks until 34.0weeks gestation or delivery which ever comes first. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Newborn Respiratory Distress Syndrome (RDS)
Newborn RDS in the twin arm is defined as compatible symptoms with radiographically confirmed hyaline membrane disease or with respiratory insufficiency of prematurity requiring ventilator support.
Data expressed as mean n(%),Odds ratio, CI, and P-value were determined using repeated measures model wherein each twin/triplet within a given pregnancy is considered a repeated measure. Exceptions are comparison with 0 outcomes in one or both groups, so Fisher's Exact Test was used.
Morbidity measures were based on live births with data available for the outcomes.
Measured: Measured from delivery until 30 days after baby was discharged from the hospital
Use of Oxygen Therapy at 28 Days of Newborn Life
Supplemental oxygen use by the baby measured at the point that the baby reaches 28 days old (after birth)within the twin group.
Measured: Measured at 28 days after birth.
Newborn Sepsis
Newborn Sepsis in the twin group was defined as the presence of positive blood culture obtained in the first week of life in association with clinical findings suggesting illness for which the neonate received antibiotics.
Measured: measured during the first week following birth
Newborn Pneumonia
Newborn Pneumonia in the twin group is described as compatible symptoms with diagnostic radiograph findings and positive results on blood cultures, persistent leukopenia
Measured: measure during the first 28 days after birth.
Newborn Intraventricular Hemorrhage Grade 3 or 4
Newborn Intraventricular hemorrhage (IVH) Stage III in the twin group is described as - IVH with ventricular dilatation.
Neonatal Intraventricular hemorrhage (IVH)Stage IV in the twin group is described as - IVH with parenchymal extension.
Measured: measured during the first 28 days after birth
Newborn Periventricular Leukomalacia (PVL)
Newborn Periventricular leukomalacia (PVL) in the twin group is described as the presence of more than 1 obvious hypo echoic cyst in the periventricular white matter.
Measured: measured in the first 28 days after birth.
Newborn Necrotizing Enterocolitis (NEC)Requiring Surgery
Newborn NEC in the twin group is described as the presence of any of the following: (1)unequivocal intramural air in abdominal radiograph; (2) perforation abdominal radiograph; (3) clinical evidence of perforation (erythema and induration of the abdominal wall or intrabdominal abscess formation); (4) characteristic findings observed at surgery or autopsy; (5) Stricture formation after an episode of suspected necrotizing enterocolitis.
Measured: measured in the first 28 days after birth
Newborn Retinopathy of Prematurity (ROP)
Newborn ROP within the twin group is described as retinopathy confirmed on fundoscopic examination, felt to be due to prematurity and subsequent oxygen therapy.
Measured: measured during the first 28 day after birth
Newborn Asphyxia With Ischemic Injury of Brain, Heart, Kidneys, or Liver
Newborn Asphyxia or Hypoxic-ischemic encephalopathy (HEI) within the twin group is characterized by clinical and laboratory evidence of acute or subacute brain injury due to asphyxia (ie, hypoxia, acidosis).
Measured: measured during the first 28 days after delivery
Perinatal Death
Perinatal death within the twin group is described as a stillbirth, neonatal death, or miscarriage after randomization.
Measured: measured from randomization to 28 days after birth.
Secondary outcomes (7)
Individual Components of Neonatal Morbidity (RDS, IVH-III/IV, Bronchopulmonary Dysplasia(BPD), PVL, Sepsis, NEC, ROP-Stage 3/4, Perinatal Death)
Composite Neonatal Morbidity within the twin group is described as the presence of any one or more of the following neonatal morbidities (RDS, IVH-III/IV, BPD, PVL, sepsis, NEC, ROP-Stage 3/4, Perinatal Death).
Measured: measured as any event noted in the first 28 day following birth.
Twins: Delivery Prior to 28 Weeks (Wks), 32 Wks, 34wks, and 37 Wks
Gestational age was noted at time of delivery and stratified into three categories (Twins: Delivery prior to 28 weeks (wks), 32 wks, 34 wks, and 37 wks)
Measured: Gestational age noted at time of birth
Triplets: Delivery Prior to 28 Wks, 32 Wks, 35 Wks
Gestational age was noted at time of delivery and stratified into three categories (Triplets: Delivery prior to 28 wks, 32 wks, 35 wks)
Measured: noted at delivery
Newborn Gestational Age (GA) at Delivery
Newborn Gestational age at delivery within the twin group is described as the gestational age of the baby on the day of birth.
Measured: determined at the time of birth
Newborn Birthweight
Newborn Birthweight within the twins group was measure following delivery and noted in grams.
Measured: measure following delivery
Participant Drop-out Rates
Drop-out rates in the twin group are described as any randomized participant who is withdrawn from the trial between randomization (as early at 16 weeks of pregnancy) and completion of the final dose of study medication (as late as 34 weeks of pregnancy).
Measured: any time from randomization to completion of final dose of study medication
Participant Side Effects Requiring Cessation of Therapy
Describe as the cessation of study related therapy for the participant within the twin group at anytime from initial study related injection until the final injection at 34 weeks of pregnancy.
Measured: anytime from initial injection to final injection at 34 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study startNov 2004
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 321 participants (actual)
Sponsor and investigators
- Lead sponsor
- Obstetrix Medical Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kimberly Maurel, RN, MSN, CNS, Study director, Obstetrix Medical Group, Inc.Andrew Combs, MD, Principal investigator, Obstetrix Medical Group, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00163020
- Sponsor's protocol ID
- OBX0003
- Other IDs
- OBX 0012
- Acronym
- 170HP
- Status last verified
- Mar 2016
- First submitted
- 9 Sep 2005
- Last updated
- 11 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Goldstein P, Berrier J, Rosen S, Sacks HS, Chalmers TC. A meta-analysis of randomized control trials of progestational agents in pregnancy. Br J Obstet Gynaecol. 1989 Mar;96(3):265-74. doi: 10.1111/j.1471-0528.1989.tb02385.x.
PubMed 2653414da Fonseca EB, Bittar RE, Carvalho MH, Zugaib M. Prophylactic administration of progesterone by vaginal suppository to reduce the incidence of spontaneous preterm birth in women at increased risk: a randomized placebo-controlled double-blind study. Am J Obstet Gynecol. 2003 Feb;188(2):419-24. doi: 10.1067/mob.2003.41.
PubMed 12592250Meis PJ, Klebanoff M, Thom E, Dombrowski MP, Sibai B, Moawad AH, Spong CY, Hauth JC, Miodovnik M, Varner MW, Leveno KJ, Caritis SN, Iams JD, Wapner RJ, Conway D, O'Sullivan MJ, Carpenter M, Mercer B, Ramin SM, Thorp JM, Peaceman AM, Gabbe S; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. N Engl J Med. 2003 Jun 12;348(24):2379-85. doi: 10.1056/NEJMoa035140.
PubMed 12802023American College of Obstetricians & Gynecologists. Special problems of multiple gestation. Educational Bulletin 253, 1998.
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 17-Alpha-Hydroxyprogesterone Caproate for Reduction of Neonatal Morbidity Due to Preterm Birth in Twin and Triplet Pregnancies - A Concurrent Randomized Double-blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT00163020
- Acronym / sponsor ID
- 170HP / OBX0003
- Conditions
- Preterm Birth
- Keywords
- Preterm Birth, Preterm Delivery, Multiple gestation, 17-alpha-hydroxyprogesterone caproate, Progesterone
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- Obstetrix Medical GroupIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 13 Sep 2005 (estimated)
- Results
- Posted 7 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypothesis: Among women with twin or triplet pregnancies, weekly injections of 17-alpha-hydroxyprogesterone caproate (17OHP), started before 24 weeks of gestation, will reduce neonatal morbidity by reducing the rate of preterm delivery.
This study involves two concurrent double-blinded randomized clinical trials of 17OHP versus placebo. Each trial will test the efficacy and safety of 17OHP in women with a specific risk factor for preterm birth. The two risk factors to be studied are:
- Twin pregnancy
- Triplet pregnancy
Detailed description
Prematurity is a leading cause of neonatal morbidity and mortality in the USA. Nationally, 12% of all babies deliver before term and 3% deliver before 32 wks gestational age (GA). Recent studies suggest that 17OHP and other progesterone derivatives may reduce the rate of preterm birth among women with a history of prior preterm birth. However, it has not been demonstrated that this reduction in preterm birth is accompanied by a clinically significant reduction in neonatal complications. Further, most women who deliver preterm have no history of a prior preterm birth. Little is known about whether progesterone treatment is effective in women with other risk factors for preterm birth such as multiple gestation. The proposed study will assess the role of 17OHP in women with twin or triplet pregnancies and will assess the impact on neonatal health, not merely the impact on gestational age at delivery. Prior studies were not designed to be large enough to have statistical power to assess effects on neonatal morbidity.
In the 6 trials combined in the Goldstein meta-analysis, only 279 women were treated with 17OHP and only 73 women had a preterm delivery. The NICHD study presented by Meis approximately doubles the world-wide experience, with 306 women under treatment, of whom 73 delivered prior to 35 wks. Yet, this study was not designed to have power to show a reduction in neonatal complications but only a reduction in preterm birth rates.
The present study is the first to be specifically designed to have adequate power to test whether 17OHP reduces neonatal morbidity among women with one of two specific risk factors for preterm birth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Test Group (170HP) | Active comparator | Drug: 17-alpha-hydroxyprogesterone caproate injectableTest Group will receive weekly doses of 170HP via injection as early as 19weeks until 34.0weeks gestation or delivery which ever comes first. |
| 2 - Control (Normal Saline) | Placebo comparator | Drug: PlaceboControl Group will receive weekly doses of placebo (NS) via injection as early as 19weeks until 34.0weeks gestation or delivery which ever comes first. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Gestational age (GA) 15-23w0d gestational age at the time of recruitment
- GA 16w0dk to 23w6d at the time of randomization and initiation of injections
- Maternal age 18 years or older
- One of these risk factors for spontaneous preterm birth:
- Intact membranes
Key exclusion criteria (8 listed)
- Symptomatic uterine contractions in current pregnancy
- Contraindication to interventions intended to prolong the pregnancy (including lethal fetal anomalies, amnionitis, preeclampsia, severe oligohydramnios, severe growth delay, fetal death appears imminent or inevitable)
- Risk factors for major neonatal morbidity unrelated to preterm delivery (such as monochorionic placentation in multiple gestation, major malformations, certain medication exposures)
- Preexisting maternal medical condition that might be worsened by progesterone therapy, including: asthma requiring medications, renal insufficiency, seizure disorder, ischemic heart disease, active cholecystitis, impaired liver function, history of thromboembolic disorder, history of breast cancer, history of major depression requiring hospitalization.
- Preexisting maternal medical condition associated with a high risk of preterm delivery including: refractory hypertension, diabetes with nephropathy or retinopathy, renal insufficiency, active systemic lupus erythematosus. Note that a history of prior preterm birth is NOT an exclusion.
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 |
|---|---|---|
| 17-alpha-hydroxyprogesterone caproate injectableAlso: 170HP250mg of 17-alpha-hydroxyprogesterone caproate (+ preservatives) injectable weekly starting as early as 19wks gestation until 34.0wks gestation of delivery which ever comes first. | Drug | 1 Test Group (170HP) |
| PlaceboAlso: Normal SalineWeekly doses of placebo (NS + preservatives) via injection as early as 19weeks until 34.0weeks gestation or delivery which ever comes first. | Drug | 2 - Control (Normal Saline) |
Primary outcome
Newborn Respiratory Distress Syndrome (RDS)
Time frame: Measured from delivery until 30 days after baby was discharged from the hospital
Newborn RDS in the twin arm is defined as compatible symptoms with radiographically confirmed hyaline membrane disease or with respiratory insufficiency of prematurity requiring ventilator support. Data expressed as mean n(%),Odds ratio, CI, and P-value were determined using repeated measures model wherein each twin/triplet within a given pregnancy is considered a repeated measure. Exceptions are comparison with 0 outcomes in one or both groups, so Fisher's Exact Test was used. Morbidity measures were based on live births with data available for the outcomes.
Use of Oxygen Therapy at 28 Days of Newborn Life
Time frame: Measured at 28 days after birth.
Supplemental oxygen use by the baby measured at the point that the baby reaches 28 days old (after birth)within the twin group.
Newborn Sepsis
Time frame: measured during the first week following birth
Newborn Sepsis in the twin group was defined as the presence of positive blood culture obtained in the first week of life in association with clinical findings suggesting illness for which the neonate received antibiotics.
Newborn Pneumonia
Time frame: measure during the first 28 days after birth.
Newborn Pneumonia in the twin group is described as compatible symptoms with diagnostic radiograph findings and positive results on blood cultures, persistent leukopenia
Newborn Intraventricular Hemorrhage Grade 3 or 4
Time frame: measured during the first 28 days after birth
Newborn Intraventricular hemorrhage (IVH) Stage III in the twin group is described as - IVH with ventricular dilatation. Neonatal Intraventricular hemorrhage (IVH)Stage IV in the twin group is described as - IVH with parenchymal extension.
Newborn Periventricular Leukomalacia (PVL)
Time frame: measured in the first 28 days after birth.
Newborn Periventricular leukomalacia (PVL) in the twin group is described as the presence of more than 1 obvious hypo echoic cyst in the periventricular white matter.
Newborn Necrotizing Enterocolitis (NEC)Requiring Surgery
Time frame: measured in the first 28 days after birth
Newborn NEC in the twin group is described as the presence of any of the following: (1)unequivocal intramural air in abdominal radiograph; (2) perforation abdominal radiograph; (3) clinical evidence of perforation (erythema and induration of the abdominal wall or intrabdominal abscess formation); (4) characteristic findings observed at surgery or autopsy; (5) Stricture formation after an episode of suspected necrotizing enterocolitis.
Newborn Retinopathy of Prematurity (ROP)
Time frame: measured during the first 28 day after birth
Newborn ROP within the twin group is described as retinopathy confirmed on fundoscopic examination, felt to be due to prematurity and subsequent oxygen therapy.
Newborn Asphyxia With Ischemic Injury of Brain, Heart, Kidneys, or Liver
Time frame: measured during the first 28 days after delivery
Newborn Asphyxia or Hypoxic-ischemic encephalopathy (HEI) within the twin group is characterized by clinical and laboratory evidence of acute or subacute brain injury due to asphyxia (ie, hypoxia, acidosis).
Perinatal Death
Time frame: measured from randomization to 28 days after birth.
Perinatal death within the twin group is described as a stillbirth, neonatal death, or miscarriage after randomization.
7 secondary outcomes
Individual Components of Neonatal Morbidity (RDS, IVH-III/IV, Bronchopulmonary Dysplasia(BPD), PVL, Sepsis, NEC, ROP-Stage 3/4, Perinatal Death)
Time frame: measured as any event noted in the first 28 day following birth.
Twins: Delivery Prior to 28 Weeks (Wks), 32 Wks, 34wks, and 37 Wks
Time frame: Gestational age noted at time of birth
Triplets: Delivery Prior to 28 Wks, 32 Wks, 35 Wks
Time frame: noted at delivery
Newborn Gestational Age (GA) at Delivery
Time frame: determined at the time of birth
Newborn Birthweight
Time frame: measure following delivery
Participant Drop-out Rates
Time frame: any time from randomization to completion of final dose of study medication
Participant Side Effects Requiring Cessation of Therapy
Time frame: anytime from initial injection to final injection at 34 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 2653414Goldstein P, Berrier J, Rosen S, Sacks HS, Chalmers TC. A meta-analysis of randomized control trials of progestational agents in pregnancy. Br J Obstet Gynaecol. 1989 Mar;96(3):265-74. doi: 10.1111/j.1471-0528.1989.tb02385.x.
- Background: PubMed 12592250da Fonseca EB, Bittar RE, Carvalho MH, Zugaib M. Prophylactic administration of progesterone by vaginal suppository to reduce the incidence of spontaneous preterm birth in women at increased risk: a randomized placebo-controlled double-blind study. Am J Obstet Gynecol. 2003 Feb;188(2):419-24. doi: 10.1067/mob.2003.41.
- Background: PubMed 12802023Meis PJ, Klebanoff M, Thom E, Dombrowski MP, Sibai B, Moawad AH, Spong CY, Hauth JC, Miodovnik M, Varner MW, Leveno KJ, Caritis SN, Iams JD, Wapner RJ, Conway D, O'Sullivan MJ, Carpenter M, Mercer B, Ramin SM, Thorp JM, Peaceman AM, Gabbe S; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. N Engl J Med. 2003 Jun 12;348(24):2379-85. doi: 10.1056/NEJMoa035140.
- BackgroundAmerican College of Obstetricians & Gynecologists. Special problems of multiple gestation. Educational Bulletin 253, 1998.
- Individual participant dataSharing planned: Undecided
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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.
Kimberly Maurel, RN, MSN, CNS study director
Obstetrix Medical Group, Inc.
Andrew Combs, MD principal investigator
Obstetrix Medical Group, Inc.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 17-alpha-hydroxyprogesterone caproate injectable in people with Preterm Birth, run by Obstetrix Medical Group at 18 sites 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 9 inclusion and 8 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 11 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Newborn Respiratory Distress Syndrome (RDS) (time frame: Measured from delivery until 30 days after baby was discharged from the hospital). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00163020, which also lists 4 linked publications.
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 11 Apr 2016.