Trial Outcomes & Findings for Relationship Between Plasma Concentration of Hydroxyprogesterone Caproate (17-OHPC) and Preterm Birth (NCT NCT03292731)

Last Updated: 2023-10-23

Results Overview

relationship between the rate of spontaneous preterm birth ( delivery \< 37 weeks) and drug concentration obtained at 26-30 weeks among those with a blood sample and adherent to study protocol (n=116)

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

159 participants

Primary outcome timeframe

26-30 week blood sample after a minimum of 7 injections among those with a blood sample and compliant with protocol(n=116)

Results posted on

2023-10-23

Participant Flow

Participant milestones

Participant milestones
Measure	Hydroxyprogesterone Caproate 250 mg RCT Component Pregnant subject will be randomized either to 250mg or 500 mg of hydroxyprogesterone caproate Intramuscular .	Hydroxyprogesterone Caproate 500 mg RCT Component Participants wil be randomized to either 250 mg or a 500 mg dose	250 mg 17-OHPC Ancillary Component subjects already on 17-OHPC will be enrolled and followed
Overall Study STARTED	67	76	16
Overall Study COMPLETED	63	65	15
Overall Study NOT COMPLETED	4	11	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Hydroxyprogesterone Caproate 250 mg RCT Component Pregnant subject will be randomized either to 250mg or 500 mg of hydroxyprogesterone caproate Intramuscular .	Hydroxyprogesterone Caproate 500 mg RCT Component Participants wil be randomized to either 250 mg or a 500 mg dose	250 mg 17-OHPC Ancillary Component subjects already on 17-OHPC will be enrolled and followed
Overall Study Protocol Violation	4	11	1

Baseline Characteristics

Relationship Between Plasma Concentration of Hydroxyprogesterone Caproate (17-OHPC) and Preterm Birth

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hydroxyprogesterone Caproate 250 mg RCT Cohort n=67 Participants Pregnant subjects randomized to 250mg of hydroxyprogesterone caproate RCT cohort	Hydroxyprogesterone Caproate 500 mg RCT Cohort n=76 Participants Pregnant subjects randomized to 500 mg of hydroxyprogesterone caproate RCT cohort	Hydroxyprogesterone Caproate 250 mg Ancillary Cohort n=16 Participants Pregnant subjects receiving 250 mg of hydroxyprogesterone caproate Ancillary cohort	Total n=159 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	67 Participants n=5 Participants	76 Participants n=7 Participants	16 Participants n=5 Participants	159 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	30.8 years STANDARD_DEVIATION 5.5 • n=5 Participants	30.5 years STANDARD_DEVIATION 5.4 • n=7 Participants	32.7 years STANDARD_DEVIATION 3.3 • n=5 Participants	30.8 years STANDARD_DEVIATION 5.3 • n=4 Participants
Sex: Female, Male Female	67 Participants n=5 Participants	76 Participants n=7 Participants	16 Participants n=5 Participants	159 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	13 Participants n=7 Participants	0 Participants n=5 Participants	20 Participants n=4 Participants
Race (NIH/OMB) White	56 Participants n=5 Participants	61 Participants n=7 Participants	16 Participants n=5 Participants	133 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	67 Participants n=5 Participants	76 Participants n=7 Participants	16 Participants n=5 Participants	159 Participants n=4 Participants

PRIMARY outcome

Timeframe: 26-30 week blood sample after a minimum of 7 injections among those with a blood sample and compliant with protocol(n=116)

Population: the primary outcome was pre-specified as only applying to those receiving either 250 mg or 500 mg dose and having a blood sample drawn according to protocol and having received at least 7 injections (n=116). The number of sPTBs is listed by group in the outcome table.

Outcome measures

Outcome measures
Measure	Ancillary -250 mg n=14 Participants Ancillary group receiving 250 mg not randomized	RCT Group 250 mg Dose n=48 Participants this group was randomized to 250 mg dose	RCT Group -500 mg Dose n=54 Participants This group randomized to 500 mg	Summarized OHPC n=116 Participants Includes all 17-OHPC values across groups
Relationship Between 17-OHPC Concentration and Spontaneous Preterm Birth - A Concentration-Response Analysis	1 Participants	9 Participants	12 Participants	22 Participants

PRIMARY outcome

Timeframe: time in days from first injection to spontaneous preterm delivery

Population: Subjects with a blood sample and no more than two missed injections

days from first injection to spontaneous preterm delivery

Outcome measures

Outcome measures
Measure	Ancillary -250 mg n=14 Participants Ancillary group receiving 250 mg not randomized	RCT Group 250 mg Dose n=48 Participants this group was randomized to 250 mg dose	RCT Group -500 mg Dose n=54 Participants This group randomized to 500 mg	Summarized OHPC n=116 Participants Includes all 17-OHPC values across groups
Survival A	150 days Standard Deviation 37	144 days Standard Deviation 17	145 days Standard Deviation 19	145 days Standard Deviation 21

PRIMARY outcome

Timeframe: days from blood sample time to spontaneous preterm delivery

Population: This analysis was limited to those 116 subjects with a 26-30 week blood sample who were compliant with the protocol regardless of group

days from when the 26-30 week blood sample was obtained to the gestation at spontaneous preterm birth. All blood samples were obtained after at least 7 injections were give by which time steady state would have been achieved. This analysis was limited to those with a 26-30 week blood sample who were compliant with the protocol

Outcome measures

Outcome measures
Measure	Ancillary -250 mg n=14 Participants Ancillary group receiving 250 mg not randomized	RCT Group 250 mg Dose n=48 Participants this group was randomized to 250 mg dose	RCT Group -500 mg Dose n=54 Participants This group randomized to 500 mg	Summarized OHPC n=116 Participants Includes all 17-OHPC values across groups
Survival B	74 days Standard Deviation 15	73 days Standard Deviation 18	73 days Standard Deviation 19	73 days Standard Deviation 18

SECONDARY outcome

Timeframe: till discharge from nicu up to 30 days

Composite NN outcome (fetal death, neonatal death (NND), respiratory distress syndrome, bronchopulmonary dysplasia, necrotizing enterocolitis, intraventricular hemorrhage 3 or 4, retinopathy of prematurity, hypoxic-ischemic encephalopathy, seizures.) and NICU admission

Outcome measures

Outcome measures
Measure	Ancillary -250 mg n=15 Participants Ancillary group receiving 250 mg not randomized	RCT Group 250 mg Dose n=65 Participants this group was randomized to 250 mg dose	RCT Group -500 mg Dose n=66 Participants This group randomized to 500 mg	Summarized OHPC n=146 Participants Includes all 17-OHPC values across groups
Composite Neonatal Outcome	3 Participants	10 Participants	12 Participants	25 Participants

SECONDARY outcome

Timeframe: any admission to the NICU from time of delivery to time of discharge from the hospital up to 30 days or transfer to another facility

Population: Only includes those neonates exposed to 17-OHPC who's mothers were randomized to either the 250 mg or 500 mg dose . Those in the ancillary study were excluded from this analysis

Infants admitted to the NICU

Outcome measures

Outcome measures
Measure	Ancillary -250 mg n=65 Participants Ancillary group receiving 250 mg not randomized	RCT Group 250 mg Dose n=66 Participants this group was randomized to 250 mg dose	RCT Group -500 mg Dose n=131 Participants This group randomized to 500 mg	Summarized OHPC Includes all 17-OHPC values across groups
NICU Admission	11 Participants	16 Participants	27 Participants	—

SECONDARY outcome

Timeframe: Blood sample obtained at 26-30 weeks after a minimum of 7 injections and compliant with study protocol

Population: Subjects with available 26-30 week specimen (after 7 injections minimum) who were compliant with protocol up to the point of the blood draw. Included those with indicated preterm birth. . The subjects received either a 250 mg injection or a 500 mg injection and it is not relevant whether she was in the RCT or ancillary group. Those receiving the 250 mg dose include both the RCT and ancillary groups

Plasma concentrations of 17-OHPC after 250 or 500 mg dose. Subjects were compliant with protocol up to the 26-30 week blood draw and had a blood sample available . This included subjects with indicated preterm birth and was not limited to those with spontaneous PTB. Plasma concentration among those receiving the 250 mg dose are compared to those receiving 500 mg dose. Those receiving the 250 mg dose include both the RCT and ancillary groups.

Outcome measures

Outcome measures
Measure	Ancillary -250 mg n=66 Participants Ancillary group receiving 250 mg not randomized	RCT Group 250 mg Dose n=55 Participants this group was randomized to 250 mg dose	RCT Group -500 mg Dose This group randomized to 500 mg	Summarized OHPC Includes all 17-OHPC values across groups
Comparison of Plasma Concentration of 17-OHPC According to Dose	8.6 ng/ml Interval 6.8 to 11.5	16.2 ng/ml Interval 14.4 to 20.4	—	—

SECONDARY outcome

Timeframe: from enrollment till preterm delivery

Population: Those receiving the 250 mg dose include both the RCT and ancillary groups

rate of preterm birth according to dosing group. Subjects were the same cohort in spec aims 1 and 2 . They were compliant with protocol, had a 26-30 week blood sample and did not miss more than 2 injections.

Outcome measures

Outcome measures
Measure	Ancillary -250 mg n=54 Participants Ancillary group receiving 250 mg not randomized	RCT Group 250 mg Dose n=62 Participants this group was randomized to 250 mg dose	RCT Group -500 mg Dose This group randomized to 500 mg	Summarized OHPC Includes all 17-OHPC values across groups
Preterm Birth by Dosing Group	7 Participants	9 Participants	—	—

Adverse Events

250 mg Dose

Serious events: 19 serious events

Other events: 53 other events

Deaths: 0 deaths

500 mg Dose

Serious events: 17 serious events

Other events: 57 other events

Deaths: 0 deaths

All Groups

Serious events: 36 serious events

Other events: 121 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	250 mg Dose n=65 participants at risk subject receiving 250mg of hydroxyprogesterone caproate	500 mg Dose n=66 participants at risk Pregnant subject receiving 500mg of hydroxyprogesterone caproate	All Groups n=131 participants at risk all groups included Ancillary and both RCTs
Psychiatric disorders suicidal ideation	0.00% 0/65 • Among those receiving either 250 mg or 500 mg OHPC adverse events were monitored from first injection until delivery for the mother up to 42 weeks gestation. This includes those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug. Adverse events are self reported by subjects and questioning was open ended without any direction by staff. Adverse events were analyzed by dose, the grouping by RCT or Ancillary is not relevant. Those receiving the 250 mg dose include both the RCT and ancillary groups. Subjects for this analysis included those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug.	1.5% 1/66 • Number of events 1 • Among those receiving either 250 mg or 500 mg OHPC adverse events were monitored from first injection until delivery for the mother up to 42 weeks gestation. This includes those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug. Adverse events are self reported by subjects and questioning was open ended without any direction by staff. Adverse events were analyzed by dose, the grouping by RCT or Ancillary is not relevant. Those receiving the 250 mg dose include both the RCT and ancillary groups. Subjects for this analysis included those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug.	0.76% 1/131 • Number of events 1 • Among those receiving either 250 mg or 500 mg OHPC adverse events were monitored from first injection until delivery for the mother up to 42 weeks gestation. This includes those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug. Adverse events are self reported by subjects and questioning was open ended without any direction by staff. Adverse events were analyzed by dose, the grouping by RCT or Ancillary is not relevant. Those receiving the 250 mg dose include both the RCT and ancillary groups. Subjects for this analysis included those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug.
Pregnancy, puerperium and perinatal conditions SAEs unrelated to drug therapy	29.2% 19/65 • Number of events 19 • Among those receiving either 250 mg or 500 mg OHPC adverse events were monitored from first injection until delivery for the mother up to 42 weeks gestation. This includes those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug. Adverse events are self reported by subjects and questioning was open ended without any direction by staff. Adverse events were analyzed by dose, the grouping by RCT or Ancillary is not relevant. Those receiving the 250 mg dose include both the RCT and ancillary groups. Subjects for this analysis included those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug.	24.2% 16/66 • Number of events 16 • Among those receiving either 250 mg or 500 mg OHPC adverse events were monitored from first injection until delivery for the mother up to 42 weeks gestation. This includes those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug. Adverse events are self reported by subjects and questioning was open ended without any direction by staff. Adverse events were analyzed by dose, the grouping by RCT or Ancillary is not relevant. Those receiving the 250 mg dose include both the RCT and ancillary groups. Subjects for this analysis included those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug.	26.7% 35/131 • Number of events 35 • Among those receiving either 250 mg or 500 mg OHPC adverse events were monitored from first injection until delivery for the mother up to 42 weeks gestation. This includes those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug. Adverse events are self reported by subjects and questioning was open ended without any direction by staff. Adverse events were analyzed by dose, the grouping by RCT or Ancillary is not relevant. Those receiving the 250 mg dose include both the RCT and ancillary groups. Subjects for this analysis included those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug.

Other adverse events

Other adverse events
Measure	250 mg Dose n=65 participants at risk subject receiving 250mg of hydroxyprogesterone caproate	500 mg Dose n=66 participants at risk Pregnant subject receiving 500mg of hydroxyprogesterone caproate	All Groups n=131 participants at risk all groups included Ancillary and both RCTs
Musculoskeletal and connective tissue disorders injection site reaction	81.5% 53/65 • Number of events 53 • Among those receiving either 250 mg or 500 mg OHPC adverse events were monitored from first injection until delivery for the mother up to 42 weeks gestation. This includes those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug. Adverse events are self reported by subjects and questioning was open ended without any direction by staff. Adverse events were analyzed by dose, the grouping by RCT or Ancillary is not relevant. Those receiving the 250 mg dose include both the RCT and ancillary groups. Subjects for this analysis included those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug.	86.4% 57/66 • Number of events 57 • Among those receiving either 250 mg or 500 mg OHPC adverse events were monitored from first injection until delivery for the mother up to 42 weeks gestation. This includes those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug. Adverse events are self reported by subjects and questioning was open ended without any direction by staff. Adverse events were analyzed by dose, the grouping by RCT or Ancillary is not relevant. Those receiving the 250 mg dose include both the RCT and ancillary groups. Subjects for this analysis included those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug.	84.0% 110/131 • Number of events 110 • Among those receiving either 250 mg or 500 mg OHPC adverse events were monitored from first injection until delivery for the mother up to 42 weeks gestation. This includes those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug. Adverse events are self reported by subjects and questioning was open ended without any direction by staff. Adverse events were analyzed by dose, the grouping by RCT or Ancillary is not relevant. Those receiving the 250 mg dose include both the RCT and ancillary groups. Subjects for this analysis included those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug.
Vascular disorders headache	36.9% 24/65 • Number of events 24 • Among those receiving either 250 mg or 500 mg OHPC adverse events were monitored from first injection until delivery for the mother up to 42 weeks gestation. This includes those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug. Adverse events are self reported by subjects and questioning was open ended without any direction by staff. Adverse events were analyzed by dose, the grouping by RCT or Ancillary is not relevant. Those receiving the 250 mg dose include both the RCT and ancillary groups. Subjects for this analysis included those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug.	31.8% 21/66 • Number of events 21 • Among those receiving either 250 mg or 500 mg OHPC adverse events were monitored from first injection until delivery for the mother up to 42 weeks gestation. This includes those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug. Adverse events are self reported by subjects and questioning was open ended without any direction by staff. Adverse events were analyzed by dose, the grouping by RCT or Ancillary is not relevant. Those receiving the 250 mg dose include both the RCT and ancillary groups. Subjects for this analysis included those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug.	32.8% 43/131 • Number of events 43 • Among those receiving either 250 mg or 500 mg OHPC adverse events were monitored from first injection until delivery for the mother up to 42 weeks gestation. This includes those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug. Adverse events are self reported by subjects and questioning was open ended without any direction by staff. Adverse events were analyzed by dose, the grouping by RCT or Ancillary is not relevant. Those receiving the 250 mg dose include both the RCT and ancillary groups. Subjects for this analysis included those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug.
Gastrointestinal disorders nausea	26.2% 17/65 • Number of events 17 • Among those receiving either 250 mg or 500 mg OHPC adverse events were monitored from first injection until delivery for the mother up to 42 weeks gestation. This includes those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug. Adverse events are self reported by subjects and questioning was open ended without any direction by staff. Adverse events were analyzed by dose, the grouping by RCT or Ancillary is not relevant. Those receiving the 250 mg dose include both the RCT and ancillary groups. Subjects for this analysis included those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug.	21.2% 14/66 • Number of events 14 • Among those receiving either 250 mg or 500 mg OHPC adverse events were monitored from first injection until delivery for the mother up to 42 weeks gestation. This includes those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug. Adverse events are self reported by subjects and questioning was open ended without any direction by staff. Adverse events were analyzed by dose, the grouping by RCT or Ancillary is not relevant. Those receiving the 250 mg dose include both the RCT and ancillary groups. Subjects for this analysis included those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug.	23.7% 31/131 • Number of events 31 • Among those receiving either 250 mg or 500 mg OHPC adverse events were monitored from first injection until delivery for the mother up to 42 weeks gestation. This includes those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug. Adverse events are self reported by subjects and questioning was open ended without any direction by staff. Adverse events were analyzed by dose, the grouping by RCT or Ancillary is not relevant. Those receiving the 250 mg dose include both the RCT and ancillary groups. Subjects for this analysis included those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug.
Gastrointestinal disorders diarrhea	18.5% 12/65 • Number of events 12 • Among those receiving either 250 mg or 500 mg OHPC adverse events were monitored from first injection until delivery for the mother up to 42 weeks gestation. This includes those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug. Adverse events are self reported by subjects and questioning was open ended without any direction by staff. Adverse events were analyzed by dose, the grouping by RCT or Ancillary is not relevant. Those receiving the 250 mg dose include both the RCT and ancillary groups. Subjects for this analysis included those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug.	10.6% 7/66 • Number of events 7 • Among those receiving either 250 mg or 500 mg OHPC adverse events were monitored from first injection until delivery for the mother up to 42 weeks gestation. This includes those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug. Adverse events are self reported by subjects and questioning was open ended without any direction by staff. Adverse events were analyzed by dose, the grouping by RCT or Ancillary is not relevant. Those receiving the 250 mg dose include both the RCT and ancillary groups. Subjects for this analysis included those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug.	14.5% 19/131 • Number of events 19 • Among those receiving either 250 mg or 500 mg OHPC adverse events were monitored from first injection until delivery for the mother up to 42 weeks gestation. This includes those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug. Adverse events are self reported by subjects and questioning was open ended without any direction by staff. Adverse events were analyzed by dose, the grouping by RCT or Ancillary is not relevant. Those receiving the 250 mg dose include both the RCT and ancillary groups. Subjects for this analysis included those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug.
Gastrointestinal disorders vomiting	16.9% 11/65 • Number of events 11 • Among those receiving either 250 mg or 500 mg OHPC adverse events were monitored from first injection until delivery for the mother up to 42 weeks gestation. This includes those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug. Adverse events are self reported by subjects and questioning was open ended without any direction by staff. Adverse events were analyzed by dose, the grouping by RCT or Ancillary is not relevant. Those receiving the 250 mg dose include both the RCT and ancillary groups. Subjects for this analysis included those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug.	6.1% 4/66 • Number of events 4 • Among those receiving either 250 mg or 500 mg OHPC adverse events were monitored from first injection until delivery for the mother up to 42 weeks gestation. This includes those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug. Adverse events are self reported by subjects and questioning was open ended without any direction by staff. Adverse events were analyzed by dose, the grouping by RCT or Ancillary is not relevant. Those receiving the 250 mg dose include both the RCT and ancillary groups. Subjects for this analysis included those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug.	11.5% 15/131 • Number of events 15 • Among those receiving either 250 mg or 500 mg OHPC adverse events were monitored from first injection until delivery for the mother up to 42 weeks gestation. This includes those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug. Adverse events are self reported by subjects and questioning was open ended without any direction by staff. Adverse events were analyzed by dose, the grouping by RCT or Ancillary is not relevant. Those receiving the 250 mg dose include both the RCT and ancillary groups. Subjects for this analysis included those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug.
Gastrointestinal disorders abdominal pain	15.4% 10/65 • Number of events 10 • Among those receiving either 250 mg or 500 mg OHPC adverse events were monitored from first injection until delivery for the mother up to 42 weeks gestation. This includes those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug. Adverse events are self reported by subjects and questioning was open ended without any direction by staff. Adverse events were analyzed by dose, the grouping by RCT or Ancillary is not relevant. Those receiving the 250 mg dose include both the RCT and ancillary groups. Subjects for this analysis included those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug.	7.6% 5/66 • Number of events 5 • Among those receiving either 250 mg or 500 mg OHPC adverse events were monitored from first injection until delivery for the mother up to 42 weeks gestation. This includes those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug. Adverse events are self reported by subjects and questioning was open ended without any direction by staff. Adverse events were analyzed by dose, the grouping by RCT or Ancillary is not relevant. Those receiving the 250 mg dose include both the RCT and ancillary groups. Subjects for this analysis included those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug.	11.5% 15/131 • Number of events 15 • Among those receiving either 250 mg or 500 mg OHPC adverse events were monitored from first injection until delivery for the mother up to 42 weeks gestation. This includes those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug. Adverse events are self reported by subjects and questioning was open ended without any direction by staff. Adverse events were analyzed by dose, the grouping by RCT or Ancillary is not relevant. Those receiving the 250 mg dose include both the RCT and ancillary groups. Subjects for this analysis included those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug.
Gastrointestinal disorders constipation	10.8% 7/65 • Number of events 7 • Among those receiving either 250 mg or 500 mg OHPC adverse events were monitored from first injection until delivery for the mother up to 42 weeks gestation. This includes those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug. Adverse events are self reported by subjects and questioning was open ended without any direction by staff. Adverse events were analyzed by dose, the grouping by RCT or Ancillary is not relevant. Those receiving the 250 mg dose include both the RCT and ancillary groups. Subjects for this analysis included those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug.	12.1% 8/66 • Number of events 8 • Among those receiving either 250 mg or 500 mg OHPC adverse events were monitored from first injection until delivery for the mother up to 42 weeks gestation. This includes those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug. Adverse events are self reported by subjects and questioning was open ended without any direction by staff. Adverse events were analyzed by dose, the grouping by RCT or Ancillary is not relevant. Those receiving the 250 mg dose include both the RCT and ancillary groups. Subjects for this analysis included those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug.	11.5% 15/131 • Number of events 15 • Among those receiving either 250 mg or 500 mg OHPC adverse events were monitored from first injection until delivery for the mother up to 42 weeks gestation. This includes those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug. Adverse events are self reported by subjects and questioning was open ended without any direction by staff. Adverse events were analyzed by dose, the grouping by RCT or Ancillary is not relevant. Those receiving the 250 mg dose include both the RCT and ancillary groups. Subjects for this analysis included those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug.
Nervous system disorders dizziness	10.8% 7/65 • Number of events 7 • Among those receiving either 250 mg or 500 mg OHPC adverse events were monitored from first injection until delivery for the mother up to 42 weeks gestation. This includes those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug. Adverse events are self reported by subjects and questioning was open ended without any direction by staff. Adverse events were analyzed by dose, the grouping by RCT or Ancillary is not relevant. Those receiving the 250 mg dose include both the RCT and ancillary groups. Subjects for this analysis included those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug.	4.5% 3/66 • Number of events 3 • Among those receiving either 250 mg or 500 mg OHPC adverse events were monitored from first injection until delivery for the mother up to 42 weeks gestation. This includes those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug. Adverse events are self reported by subjects and questioning was open ended without any direction by staff. Adverse events were analyzed by dose, the grouping by RCT or Ancillary is not relevant. Those receiving the 250 mg dose include both the RCT and ancillary groups. Subjects for this analysis included those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug.	7.6% 10/131 • Number of events 10 • Among those receiving either 250 mg or 500 mg OHPC adverse events were monitored from first injection until delivery for the mother up to 42 weeks gestation. This includes those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug. Adverse events are self reported by subjects and questioning was open ended without any direction by staff. Adverse events were analyzed by dose, the grouping by RCT or Ancillary is not relevant. Those receiving the 250 mg dose include both the RCT and ancillary groups. Subjects for this analysis included those with indicated preterm birth or absent blood sample but excluded those who were non-compliant, lost to followup, discontinued treatment or did not receive the drug.

Additional Information

steve caritis

University of Pittsburgh

Phone: 412 641 5256

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place