Trial Outcomes & Findings for Prostin and Propess in Induction of Labor (NCT NCT01635439)

NCT ID: NCT01635439

Last Updated: 2014-02-06

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 200 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2014-02-06

Participant Flow

290 women were assessed for eligibility, 62 women were excluded (35 did not meet the inclusion criteria, 21 declined to participate and 6 refused induction of labor as a method of delivery)

Among the 228 women who met the eligibility criteria, 7 went into spontaneous labor and 4 had pathological Cardiotocography (CTG), so were excluded from being assigned to one of the treatment groups. After allocation 17 women were excluded from the analysis (15 refused to continue the induction of labor and had 5 incomplete records).

Participant milestones

Measure	Propess Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.	Prostin E2 PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
Overall Study STARTED	100	100
Overall Study COMPLETED	100	100
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prostin and Propess in Induction of Labor

Baseline characteristics by cohort

Measure	Propess n=100 Participants Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.	Prostin E2 n=100 Participants PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.	Total n=200 Participants Total of all reporting groups
Age, Continuous	26 years STANDARD_DEVIATION 4.3 • n=5 Participants	26.8 years STANDARD_DEVIATION 5.1 • n=7 Participants	26.4 years STANDARD_DEVIATION 4.7 • n=5 Participants
Sex: Female, Male Female	100 Participants n=5 Participants	100 Participants n=7 Participants	200 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Body mass index	23 kg/m^2 STANDARD_DEVIATION 2.7 • n=5 Participants	23.5 kg/m^2 STANDARD_DEVIATION 3.5 • n=7 Participants	23.3 kg/m^2 STANDARD_DEVIATION 3.1 • n=5 Participants
Parity P0	44 participants n=5 Participants	49 participants n=7 Participants	93 participants n=5 Participants
Parity P1	20 participants n=5 Participants	23 participants n=7 Participants	43 participants n=5 Participants
Parity P2	20 participants n=5 Participants	14 participants n=7 Participants	34 participants n=5 Participants
Parity P3	11 participants n=5 Participants	8 participants n=7 Participants	19 participants n=5 Participants
Parity P4	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants
Parity P5	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Gestational age	40.6 weeks STANDARD_DEVIATION 0.9 • n=5 Participants	40.4 weeks STANDARD_DEVIATION 1.3 • n=7 Participants	40.5 weeks STANDARD_DEVIATION 1.2 • n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

Outcome measures

Measure	Propess n=100 Participants Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.	Prostin E2 n=100 Participants PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
Induction to Delivery Interval	22.3 hours Standard Deviation 5.7	21.2 hours Standard Deviation 5.3

SECONDARY outcome

Timeframe: 24 hours

Outcome measures

Measure	Propess n=100 Participants Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.	Prostin E2 n=100 Participants PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
Induction to Onset of Labor Interval	18.8 hours Standard Deviation 5.3	17.7 hours Standard Deviation 5.4

SECONDARY outcome

Timeframe: 24 hours

Outcome measures

Measure	Propess n=100 Participants Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.	Prostin E2 n=100 Participants PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
Uterine Hyper-stimulation Rate	1 participants	1 participants

SECONDARY outcome

Timeframe: 24 hours

Outcome measures

Measure	Propess n=100 Participants Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.	Prostin E2 n=100 Participants PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
Need for Syntocinon Augmentation	5 participants	10 participants

SECONDARY outcome

Timeframe: 24 hours

Outcome measures

Measure	Propess n=100 Participants Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.	Prostin E2 n=100 Participants PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
Normal Vaginal Delivery Rate	79 participants	85 participants

Adverse Events

Propess

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Prostin E2

Serious events: 2 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Measure	Propess n=100 participants at risk Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.	Prostin E2 n=100 participants at risk PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
Pregnancy, puerperium and perinatal conditions Cord pH < 7.1	1.0% 1/100 • Number of events 1	2.0% 2/100 • Number of events 2

Other adverse events

Measure	Propess n=100 participants at risk Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.	Prostin E2 n=100 participants at risk PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
Pregnancy, puerperium and perinatal conditions Maternal adverse outcomes	12.0% 12/100 • Number of events 12	13.0% 13/100 • Number of events 13
Pregnancy, puerperium and perinatal conditions Apgar score < 7	0.00% 0/100	1.0% 1/100 • Number of events 1
Pregnancy, puerperium and perinatal conditions Uterine tachysystole	2.0% 2/100 • Number of events 2	3.0% 3/100 • Number of events 3

Additional Information

Ahmed Abdelaziz

NWAFH

Phone: 0096644411088

Email: webmaster@nwafh.med.sa

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place