Trial Outcomes & Findings for Evaluation of CRB in PROM Patients (NCT NCT01736852)
NCT ID: NCT01736852
Last Updated: 2020-10-20
Results Overview
Time, in minutes, from the start of labor induction through delivery
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
129 participants
Primary outcome timeframe
Start of labor induction through delivery, an expected average of 6 hours
Results posted on
2020-10-20
Participant Flow
Participant milestones
| Measure |
CRB Plus Pitocin
CRB: Labor induction using the CRB
Pitocin: Labor induction using Pitocin
|
Pitocin
Pitocin: Labor induction using Pitocin
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
64
|
|
Overall Study
COMPLETED
|
63
|
61
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Two Patients (one in each arm) did not have their Bishop Score recorded.
Baseline characteristics by cohort
| Measure |
CRB Plus Pitocin
n=64 Participants
CRB: Labor induction using the CRB
Pitocin: Labor induction using Pitocin
|
Pitocin
n=61 Participants
Pitocin: Labor induction using Pitocin
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.0 years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
26.3 years
STANDARD_DEVIATION 5.5 • n=7 Participants
|
25.7 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
First Nation
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
29 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino/White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
18 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Multiple (2 or more) previous pregnancies
|
31 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Bishop score at time of enrollment
|
4.4 units on a scale
STANDARD_DEVIATION 1.4 • n=5 Participants • Two Patients (one in each arm) did not have their Bishop Score recorded.
|
4.1 units on a scale
STANDARD_DEVIATION 1.4 • n=7 Participants • Two Patients (one in each arm) did not have their Bishop Score recorded.
|
4.2 units on a scale
STANDARD_DEVIATION 1.5 • n=5 Participants • Two Patients (one in each arm) did not have their Bishop Score recorded.
|
|
Gestational age (weeks/days)
34/0 - 36/6
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Gestational age (weeks/days)
37/0 - 42/6
|
52 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Start of labor induction through delivery, an expected average of 6 hoursTime, in minutes, from the start of labor induction through delivery
Outcome measures
| Measure |
CRB Plus Pitocin
n=63 Participants
CRB: Labor induction using the CRB
Pitocin: Labor induction using Pitocin
|
Pitocin
n=61 Participants
Pitocin: Labor induction using Pitocin
|
|---|---|---|
|
Time of Labor
|
850.4 Minutes
Standard Deviation 417.6
|
1016.6 Minutes
Standard Deviation 595.7
|
PRIMARY outcome
Timeframe: Through hospital discharge, an expected average of 3 daysnumber of patients with chorioamnionitis
Outcome measures
| Measure |
CRB Plus Pitocin
n=63 Participants
CRB: Labor induction using the CRB
Pitocin: Labor induction using Pitocin
|
Pitocin
n=61 Participants
Pitocin: Labor induction using Pitocin
|
|---|---|---|
|
Incidence of Infection
|
7 Participants
|
6 Participants
|
Adverse Events
CRB Plus Pitocin
Serious events: 5 serious events
Other events: 27 other events
Deaths: 0 deaths
Pitocin
Serious events: 4 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CRB Plus Pitocin
n=63 participants at risk
CRB: Labor induction using the CRB
Pitocin: Labor induction using Pitocin
|
Pitocin
n=61 participants at risk
Pitocin: Labor induction using Pitocin
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Jaundice Neonatal
|
1.6%
1/63 • Number of events 1 • 0-30 Days
|
1.6%
1/61 • Number of events 1 • 0-30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal Hypoxia
|
0.00%
0/63 • 0-30 Days
|
1.6%
1/61 • Number of events 1 • 0-30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory distress syndrome
|
1.6%
1/63 • Number of events 1 • 0-30 Days
|
0.00%
0/61 • 0-30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Infantile Apnea
|
0.00%
0/63 • 0-30 Days
|
1.6%
1/61 • Number of events 1 • 0-30 Days
|
|
Pregnancy, puerperium and perinatal conditions
Postpartum hemorrhage
|
3.2%
2/63 • Number of events 2 • 0-30 Days
|
0.00%
0/61 • 0-30 Days
|
|
Pregnancy, puerperium and perinatal conditions
Arrested Labor
|
1.6%
1/63 • Number of events 1 • 0-30 Days
|
1.6%
1/61 • Number of events 1 • 0-30 Days
|
|
Pregnancy, puerperium and perinatal conditions
Umbilical Cord Prolapse
|
1.6%
1/63 • Number of events 1 • 0-30 Days
|
0.00%
0/61 • 0-30 Days
|
Other adverse events
| Measure |
CRB Plus Pitocin
n=63 participants at risk
CRB: Labor induction using the CRB
Pitocin: Labor induction using Pitocin
|
Pitocin
n=61 participants at risk
Pitocin: Labor induction using Pitocin
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Arrested Labor
|
11.1%
7/63 • Number of events 7 • 0-30 Days
|
21.3%
13/61 • Number of events 13 • 0-30 Days
|
|
Infections and infestations
Amniotic Cavity Infection
|
11.1%
7/63 • Number of events 7 • 0-30 Days
|
9.8%
6/61 • Number of events 6 • 0-30 Days
|
|
Pregnancy, puerperium and perinatal conditions
Jaundice Neonatal
|
22.2%
14/63 • Number of events 14 • 0-30 Days
|
8.2%
5/61 • Number of events 5 • 0-30 Days
|
Additional Information
Alan Saunders,MS, RAC; Manager, Biostatistics
Cook Research Incorporated
Phone: 765-463-7537
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review results communications from PI prior to public release and can embargo communications of trial results between 60 and 180 days from the time submitted to the sponsor for review. The sponsor can embargo publications until the sponsor has published results or 180 days has elapsed after study closure at all participating sites. The sponsor cannot restrict publication but can require changes to protect sponsor's intellectual property rights or other confidential information.
- Publication restrictions are in place
Restriction type: OTHER