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17OHP for Reduction of Neonatal Morbidity Due to Preterm Birth (PTB) in Twin and Triplet Pregnancies (170HP)

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ClinicalTrials.gov Identifier: NCT00163020
Recruitment Status : Completed
First Posted : September 13, 2005
Results First Posted : November 7, 2012
Last Update Posted : April 11, 2016
Sponsor:
Information provided by (Responsible Party):
Mednax Center for Research, Education, Quality and Safety ( Obstetrix Medical Group )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Preterm Birth
Interventions Drug: 17-alpha-hydroxyprogesterone caproate injectable
Drug: Placebo
Enrollment 321
Recruitment Details Potential women carrying a twin or triplet pregnancy meeting defined inclusion and exclusion criteria were recruited from participating outpatient medical clinics from November, 2004 to August 2009.
Pre-assignment Details During the pre-assignment period, subjects were consented to participate, giving a compliance injection of Castor Oil and brought back 5 to 9 days later for re-evaluation. Exclusions were made based on the presence of a reaction to the injection, not meeting inclusion/exclusion criteria or the participates desire not to participate.
Arm/Group Title 1 Test Group (170HP) 2 - Control (Castor Oil)
Hide Arm/Group Description Test Group will receive a weekly dose of 170HP via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever comes first. Control Group will receive a weekly dose of placebo (castor oil) via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever comes first.
Period Title: Overall Study
Started 216 [1] 105 [2]
Completed 216 [1] 103 [3]
Not Completed 0 2
Reason Not Completed
Lost to Follow-up             0             2
[1]
Twins = 160 Triplets = 56
[2]
Twins = 80 Triplets = 25
[3]
Twins = 78 Triplets = 25
Arm/Group Title 1 Test Group (170HP) 2 - Control (Castor Oil) Total
Hide Arm/Group Description Test Group will receive a weekly dose of 170HP via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever comes first. Control Group will receive a weekly dose of placebo (castor oil) via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever comes first. Total of all reporting groups
Overall Number of Baseline Participants 216 105 321
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 216 participants 105 participants 321 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
216
 100.0%
105
 100.0%
321
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 216 participants 105 participants 321 participants
twins 34.0  (5.8) 34.5  (6.6) 34.3  (6.2)
triplets 33.4  (5.0) 33.6  (5.4) 33.5  (5.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 216 participants 105 participants 321 participants
Female
216
 100.0%
105
 100.0%
321
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 216 participants 105 participants 321 participants
216 105 321
1.Primary Outcome
Title Newborn Respiratory Distress Syndrome (RDS)
Hide Description

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.

Time Frame Measured from delivery until 30 days after baby was discharged from the hospital
Hide Outcome Measure Data
Hide Analysis Population Description
Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (319) vs. babies born to mothers in placebo arm(153))
Arm/Group Title Twins Group = Test Arm - 17OHP Twins Group - Placebo Arm
Hide Arm/Group Description:
Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
Overall Number of Participants Analyzed 319 153
Measure Type: Number
Unit of Measure: Twins
44 18
2.Primary Outcome
Title Use of Oxygen Therapy at 28 Days of Newborn Life
Hide Description Supplemental oxygen use by the baby measured at the point that the baby reaches 28 days old (after birth)within the twin group.
Time Frame Measured at 28 days after birth.
Hide Outcome Measure Data
Hide Analysis Population Description
Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (308) vs. babies born to mothers in placebo arm(150))
Arm/Group Title Twins Group = Test Arm - 17OHP Twins Group - Placebo Arm
Hide Arm/Group Description:
Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
Overall Number of Participants Analyzed 308 150
Measure Type: Number
Unit of Measure: Twins
9 0
3.Primary Outcome
Title Newborn Sepsis
Hide Description 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.
Time Frame measured during the first week following birth
Hide Outcome Measure Data
Hide Analysis Population Description
The participants were randomized in a two to one fashion (2=active participants to every 1=placebo participant). The number of participated included were based on an intent to treat protocol.
Arm/Group Title Twins Group = Test Arm - 17OHP Twins Group - Placebo Arm
Hide Arm/Group Description:
Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
Overall Number of Participants Analyzed 319 154
Measure Type: Number
Unit of Measure: participants
3 1
4.Primary Outcome
Title Newborn Pneumonia
Hide Description Newborn Pneumonia in the twin group is described as compatible symptoms with diagnostic radiograph findings and positive results on blood cultures, persistent leukopenia
Time Frame measure during the first 28 days after birth.
Hide Outcome Measure Data
Hide Analysis Population Description
Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (320) vs. babies born to mothers in placebo arm(154))
Arm/Group Title Twins Group = Test Arm - 17OHP Twins Group - Placebo Arm
Hide Arm/Group Description:
Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
Overall Number of Participants Analyzed 320 154
Measure Type: Number
Unit of Measure: Twins
1 0
5.Primary Outcome
Title Newborn Intraventricular Hemorrhage Grade 3 or 4
Hide Description

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.

Time Frame measured during the first 28 days after birth
Hide Outcome Measure Data
Hide Analysis Population Description
Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (316) vs. babies born to mothers in placebo arm(152))
Arm/Group Title Twins Group = Test Arm - 17OHP Twins Group - Placebo Arm
Hide Arm/Group Description:
Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
Overall Number of Participants Analyzed 316 152
Measure Type: Number
Unit of Measure: Twins
3 0
6.Primary Outcome
Title Newborn Periventricular Leukomalacia (PVL)
Hide Description 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.
Time Frame measured in the first 28 days after birth.
Hide Outcome Measure Data
Hide Analysis Population Description
The participants were randomized in a two to one fashion (2=active participants to every 1=placebo participant). The number of participants for analysis was determined using an intention to treat protocol.
Arm/Group Title Twins Group = Test Arm - 17OHP Twins Group - Placebo Arm
Hide Arm/Group Description:
Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
Overall Number of Participants Analyzed 316 151
Measure Type: Number
Unit of Measure: participants
1 1
7.Primary Outcome
Title Newborn Necrotizing Enterocolitis (NEC)Requiring Surgery
Hide Description 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.
Time Frame measured in the first 28 days after birth
Hide Outcome Measure Data
Hide Analysis Population Description
Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (315) vs. babies born to mothers in placebo arm(152))
Arm/Group Title Twins Group = Test Arm - 17OHP Twins Group - Placebo Arm
Hide Arm/Group Description:
Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
Overall Number of Participants Analyzed 315 152
Measure Type: Number
Unit of Measure: Twins
0 0
8.Primary Outcome
Title Newborn Retinopathy of Prematurity (ROP)
Hide Description Newborn ROP within the twin group is described as retinopathy confirmed on fundoscopic examination, felt to be due to prematurity and subsequent oxygen therapy.
Time Frame measured during the first 28 day after birth
Hide Outcome Measure Data
Hide Analysis Population Description
Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (308) vs. babies born to mothers in placebo arm(145))
Arm/Group Title Twins Group = Test Arm - 17OHP Twins Group - Placebo Arm
Hide Arm/Group Description:
Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
Overall Number of Participants Analyzed 308 145
Measure Type: Number
Unit of Measure: Twins
2 0
9.Primary Outcome
Title Newborn Asphyxia With Ischemic Injury of Brain, Heart, Kidneys, or Liver
Hide Description 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).
Time Frame measured during the first 28 days after delivery
Hide Outcome Measure Data
Hide Analysis Population Description
Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (274) vs. babies born to mothers in placebo arm(130))
Arm/Group Title Twins Group = Test Arm - 17OHP Twins Group - Placebo Arm
Hide Arm/Group Description:
Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
Overall Number of Participants Analyzed 274 130
Measure Type: Number
Unit of Measure: Twins
0 0
10.Primary Outcome
Title Perinatal Death
Hide Description Perinatal death within the twin group is described as a stillbirth, neonatal death, or miscarriage after randomization.
Time Frame measured from randomization to 28 days after birth.
Hide Outcome Measure Data
Hide Analysis Population Description
Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (320) vs. babies born to mothers in placebo arm(156))
Arm/Group Title Twins Group = Test Arm - 17OHP Twins Group - Placebo Arm
Hide Arm/Group Description:
Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
Overall Number of Participants Analyzed 320 156
Measure Type: Number
Unit of Measure: Twins
0 3
11.Secondary Outcome
Title Individual Components of Neonatal Morbidity (RDS, IVH-III/IV, Bronchopulmonary Dysplasia(BPD), PVL, Sepsis, NEC, ROP-Stage 3/4, Perinatal Death)
Hide Description 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).
Time Frame measured as any event noted in the first 28 day following birth.
Hide Outcome Measure Data
Hide Analysis Population Description
Population analysed were total Twin infants delivered to mothers within each study arm. (ie. babies born to moms in active arm (320) vs. babies born to mothers in placebo arm(155))
Arm/Group Title Twins Group = Test Arm - 17OHP Twins Group - Placebo Arm
Hide Arm/Group Description:
Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
Overall Number of Participants Analyzed 320 155
Measure Type: Number
Unit of Measure: Twins - Components of Neonatal Morbidity
46 19
12.Secondary Outcome
Title Twins: Delivery Prior to 28 Weeks (Wks), 32 Wks, 34wks, and 37 Wks
Hide Description 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)
Time Frame Gestational age noted at time of birth
Hide Outcome Measure Data
Hide Analysis Population Description
Population analysed were total pregnancies of mothers with twin gestation (ie. active group 160 and placebo group 80)
Arm/Group Title Twins Group = Test Arm - 17OHP Twins Group - Placebo Arm
Hide Arm/Group Description:
Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
Overall Number of Participants Analyzed 160 80
Measure Type: Number
Unit of Measure: Twin Pregnancies
Delivery before 28 weeks of gestation 3 1
Delivery before 32 weeks of gestation 15 4
Delivery before 34 weeks of gestation 31 11
Delivery before 37 weeks of gestation 113 46
13.Secondary Outcome
Title Triplets: Delivery Prior to 28 Wks, 32 Wks, 35 Wks
Hide Description Gestational age was noted at time of delivery and stratified into three categories (Triplets: Delivery prior to 28 wks, 32 wks, 35 wks)
Time Frame noted at delivery
Hide Outcome Measure Data
Hide Analysis Population Description
Population analysed were total pregnant mothers with triplet gestations (ie. active group 160 and placebo group 80)
Arm/Group Title Triplet Group = Test Arm - 17OHP Triplet Group - Placebo Arm
Hide Arm/Group Description:
Weekly injection of 170HP (250mg)to patients with Triplet Pregnancies
Weekly injection of Placebo medication (castor oil)to patients with Triplet Pregnancies
Overall Number of Participants Analyzed 56 25
Measure Type: Number
Unit of Measure: Triplet Pregnancies
Delivery before 28 weeks of gestation 9 2
Delivery before 32 weeks of gestation 19 13
Delivery before 35 weeks of gestation 43 13
14.Secondary Outcome
Title Newborn Gestational Age (GA) at Delivery
Hide Description Newborn Gestational age at delivery within the twin group is described as the gestational age of the baby on the day of birth.
Time Frame determined at the time of birth
Hide Outcome Measure Data
Hide Analysis Population Description
Population analysed were total pregnant mothers with twin gestations (ie. active group 160 and placebo group 80)
Arm/Group Title Twins Group = Test Arm - 17OHP Twins Group - Placebo Arm
Hide Arm/Group Description:
Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
Overall Number of Participants Analyzed 160 80
Mean (Standard Deviation)
Unit of Measure: weeks of age for twin pregnancy
35.3  (2.5) 35.9  (2.3)
15.Secondary Outcome
Title Newborn Birthweight
Hide Description Newborn Birthweight within the twins group was measure following delivery and noted in grams.
Time Frame measure following delivery
Hide Outcome Measure Data
Hide Analysis Population Description
Population analysed were twins from twin pregnancies (ie. active group 160 and placebo group 80)
Arm/Group Title Twins Group = Test Arm - 17OHP Twins Group - Placebo Arm
Hide Arm/Group Description:
Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
Overall Number of Participants Analyzed 160 78
Mean (Standard Deviation)
Unit of Measure: grams
2321  (523) 2469  (543)
16.Secondary Outcome
Title Participant Drop-out Rates
Hide Description 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).
Time Frame any time from randomization to completion of final dose of study medication
Hide Outcome Measure Data
Hide Analysis Population Description
Population analysed were total pregnant mothers (participants) with twin gestation (ie. active group 160 and placebo group 80)
Arm/Group Title Twins Group = Test Arm - 17OHP Twins Group - Placebo Arm
Hide Arm/Group Description:
Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
Overall Number of Participants Analyzed 160 80
Measure Type: Number
Unit of Measure: participants
8 5
17.Secondary Outcome
Title Participant Side Effects Requiring Cessation of Therapy
Hide Description 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.
Time Frame anytime from initial injection to final injection at 34 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
Population analysed were total pregnant mothers (participants) with twin gestation (ie. active group 160 and placebo group 80)
Arm/Group Title Twins Group = Test Arm - 17OHP Twins Group - Placebo Arm
Hide Arm/Group Description:
Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
Overall Number of Participants Analyzed 160 80
Measure Type: Number
Unit of Measure: participants
6 0
Time Frame Adverse events were collected during the 4.9 years the trial was actively enrolling subjects. For each randomized participant, adverse events were captured from randomization until the participant and her baby were discharged from the hospital.
Adverse Event Reporting Description Assessments were both Systematic & Non-systematic: standard questionnaire, regular investigator assessment, regular laboratory testing, systematic evaluation of medical record, self-reporting by participants, occasional assessment/testing
 
Arm/Group Title Test Group (170HP) Control (Castor Oil)
Hide Arm/Group Description Both Twins and Triplets in the Test Group received a weekly dose of 170HP via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever came first. Both Twins and Triplets in the Control Group received a weekly dose of placebo (castor oil) via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever came first.
All-Cause Mortality
Test Group (170HP) Control (Castor Oil)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Test Group (170HP) Control (Castor Oil)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   69/216 (31.94%)      34/105 (32.38%)    
Blood and lymphatic system disorders     
Maternal Hematoma *  0/216 (0.00%)  0 1/105 (0.95%)  1
Cardiac disorders     
Maternal Supraventricular Tachycardia (SVT) *  1/216 (0.46%)  1 1/105 (0.95%)  1
Congenital, familial and genetic disorders     
Neonatal Cardiac Abnormalities  [1]  2/216 (0.93%)  2 0/105 (0.00%)  0
Neonatal Congenital Hypospadium   2/216 (0.93%)  2 0/105 (0.00%)  0
Congenital Abnormality  [2]  3/216 (1.39%)  3 6/105 (5.71%)  6
Neonatal Peripheral Pulmonary Stenosis   1/216 (0.46%)  1 0/105 (0.00%)  0
Gastrointestinal disorders     
Neonatal Bowel Perforation   1/216 (0.46%)  1 0/105 (0.00%)  0
Neonatal Gastroschisis   1/216 (0.46%)  1 0/105 (0.00%)  0
Neonatal Necrotizing Enterocolitis (NEC)   2/216 (0.93%)  2 3/105 (2.86%)  3
General disorders     
Neonatal Readmissions to the hospital * [3]  5/216 (2.31%)  5 0/105 (0.00%)  0
Nectrotizing Enterocolitis (NEC) *  2/216 (0.93%)  2 3/105 (2.86%)  3
Infections and infestations     
Maternal Cellulitis  [4]  2/216 (0.93%)  2 0/105 (0.00%)  0
Neonatal Sepsis * [5]  3/216 (1.39%)  3 5/105 (4.76%)  5
Neonatal Meningitis *  0/216 (0.00%)  0 1/105 (0.95%)  1
Injury, poisoning and procedural complications     
Maternal Wound Eviceration post Cesarean Section *  0/216 (0.00%)  0 1/105 (0.95%)  1
Nervous system disorders     
Neonatal Cranial Synostosis   1/216 (0.46%)  1 0/105 (0.00%)  0
Neonatal Post Hemorrhagic Hydrocephalus   1/216 (0.46%)  1 0/105 (0.00%)  0
Pregnancy, puerperium and perinatal conditions     
Postpartum Hemorrhage requiring blood transfusion  1  9/216 (4.17%)  9 4/105 (3.81%)  4
Maternal Anemia  [6]  3/216 (1.39%)  3 0/105 (0.00%)  0
Maternal Chorioamnionities necessitating preterm delivery   1/216 (0.46%)  1 0/105 (0.00%)  0
Endometritis   1/216 (0.46%)  1 0/105 (0.00%)  0
Maternal HELLP Syndrome   1/216 (0.46%)  1 0/105 (0.00%)  0
Intrauterine Fetal Demise (IUFD)   1/216 (0.46%)  1 0/105 (0.00%)  0
Miscarriage   3/216 (1.39%)  3 0/105 (0.00%)  0
Peripartum Cardiomyopathy   1/216 (0.46%)  1 0/105 (0.00%)  0
Severe Pre-eclampsia   2/216 (0.93%)  2 1/105 (0.95%)  1
Uterine Atony *  1/216 (0.46%)  1 0/105 (0.00%)  0
Retained Products of Conception *  1/216 (0.46%)  1 0/105 (0.00%)  0
Renal and urinary disorders     
Prolonged Hospitalization - Maternal Urinary Retention   1/216 (0.46%)  1 0/105 (0.00%)  0
Maternal Pyelonephritis   2/216 (0.93%)  2 0/105 (0.00%)  0
Maternal Pyelonephritis *  2/216 (0.93%)  2 0/105 (0.00%)  0
Reproductive system and breast disorders     
Neonatal Pneumothorax   1/216 (0.46%)  1 0/105 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Acute Bronchitis  1  1/216 (0.46%)  1 0/105 (0.00%)  0
Neonatal Chronic Lung Disease   1/216 (0.46%)  1 1/105 (0.95%)  1
Neonatal Hypoplastic Lung   1/216 (0.46%)  1 0/105 (0.00%)  0
Neonatal Pneumonia   1/216 (0.46%)  1 4/105 (3.81%)  4
Maternal Pneumonia  [7]  1/216 (0.46%)  1 0/105 (0.00%)  0
Pulmonary Edema *  0/216 (0.00%)  0 1/105 (0.95%)  1
Surgical and medical procedures     
Bladder Trauma  [8]  1/216 (0.46%)  1 0/105 (0.00%)  0
Inguinal Hernia requiring surgical repair *  0/216 (0.00%)  0 2/105 (1.90%)  2
Vascular disorders     
Deep Vein Thrombosis (DVT)   1/216 (0.46%)  1 0/105 (0.00%)  0
Neonatal Intraventricular Hemorrhage (Stage III or IV)   4/216 (1.85%)  4 0/105 (0.00%)  0
Non-Occulusive Thrombus   1/216 (0.46%)  1 0/105 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
[1]
Neonatal Congenital Cardiac abnormalities such as Ventricular Septal Defect (VSD), Atrial Septal Defect (ASD) ,Patent Ductus Arteriosis (PDA)
[2]
neonatal congenital abnormality such as club foot, cleft palate, gastroschisis, tracheal stenosis, Hydrocele, duodenal atresia, sigmoid stricture, PDA requiring ligation.
[3]
Neonatal readmission to the hospital after discharge = such as temperature instability, sepsis, nutritional support and apnea
[4]
maternal cellulitis at intramuscular injection site
[5]
diagnosed by clinical or laboratory findings
[6]
Maternal Anemia following intrapartum bleeding.
[7]
Compatible symptoms with diagnostic radiograph findings and positive results on blood cultures,persistent leukopenia
[8]
Bladder trauma during cesarean section
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Test Group (170HP) Control (Castor Oil)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   40/216 (18.52%)      18/105 (17.14%)    
Metabolism and nutrition disorders     
Gestational Diabetes *  11/216 (5.09%)  11 5/105 (4.76%)  5
Pregnancy, puerperium and perinatal conditions     
Pre-eclampsia *  29/216 (13.43%)  29 13/105 (12.38%)  13
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kimberly Maurel
Organization: Obstetrix Medical Group, Inc
Phone: 714-593-9171
EMail: kimberly_maurel@pediatrix.com
Layout table for additonal information
Responsible Party: Mednax Center for Research, Education, Quality and Safety ( Obstetrix Medical Group )
ClinicalTrials.gov Identifier: NCT00163020     History of Changes
Other Study ID Numbers: OBX0003
OBX 0012 ( Other Identifier: Obstetrix CREQ Protocol Number )
First Submitted: September 9, 2005
First Posted: September 13, 2005
Results First Submitted: June 5, 2012
Results First Posted: November 7, 2012
Last Update Posted: April 11, 2016