Prostin and Propess in Induction of Labor

• Sponsor: Ain Shams University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01635439
• Collaborator: North West Armed Forces Hospital (Other)
• Enrollment: 200
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 16.7

Study Details

Study Description

Brief Summary

The purpose of the study was to compare the safety and efficacy of two agents used in induction of labor Propess (Controlled release dinoprostone, PGE2, pessary) and Prostin E2 (Dinoprostone vaginal Tablet).

Condition or Disease	Intervention/Treatment	Phase
Labor Pain	Drug: Propess; Drug: Prostin E2	Phase 3

Detailed Description

A controlled release hydrophilic matrix (Controlled Therapeutics Ltd., East Kilbride, Scotland) which provides a gradual release of dinoprostone (prostaglandin E2) was introduced in 1995 (Propess, Ferring Pharmaceuticals). This preparation is used for the initiation or enhancement of cervical ripening in women at or after term with a singleton pregnancy and a cephalic presentation. Prostaglandin E2 causes softening and dilatation of the cervix and subsequently produces uterine contractions which may induce labour.

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Induction of Labour: A Comparison Between Propess Vaginal Delivery System and Prostin E2 Vaginal Suppositories, A Randomized Controlled Trial.
• Study Start Date: Dec 1, 2010
• Actual Primary Completion Date: Nov 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Propess; The vaginal insert is removed 24 h after the application. It is only to be removed earlier in case of the onset of active labour, the rupture of the membranes, or at the occurrence of hyperstimulation.; Other Names: Intravaginal PGE2 insert
Active Comparator: Prostin E2 PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.	Drug: Prostin E2; 3 mg tab is placed in the posterior vaginal fornix. dose can be repeated every 6 hours till onset of active labour, the rupture of the membranes, or the occurrence of hyper-stimulation.; Other Names: Dinoprostone (PGE2)vaginal tablets.

Outcome Measures

Primary Outcome Measures

1. Induction to Delivery Interval [24 hours]

Secondary Outcome Measures

1. Induction to Onset of Labor Interval [24 hours]

2. Uterine Hyper-stimulation Rate [24 hours]

3. Need for Syntocinon Augmentation [24 hours]

4. Normal Vaginal Delivery Rate [24 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Gestational age 37 weeks or more

• Singleton pregnancy

• Cephalic presentation.

Exclusion Criteria:

• Previous cesarean section

• Any contraindication for vaginal delivery

• Suspected Cephalo-Pelvic Disproportion

• Unexplained antepartum Hemorrhage

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NWAFH, North west Armed Forces Hospital	Tabuk		Saudi Arabia	Box 100 Tabuk

Sponsors and Collaborators

• Ain Shams University
• North West Armed Forces Hospital

Investigators

• Principal Investigator: Ahmed Abdelaziz, M.D., North West Armed Forces Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mohamed Ellaithy, Lecturer of Obstetrics & Gynecology/ Consultant of Obstetrics & Gynecology AFHSR, Ain Shams University
• ClinicalTrials.gov Identifier: NCT01635439
• Other Study ID Numbers: NWAFH2010-1
• First Posted: Jul 9, 2012
• Last Update Posted: Feb 6, 2014
• Last Verified: Jan 1, 2014

• Additional relevant MeSH terms: Labor Pain; Dinoprostone

Study Results

Participant Flow

Recruitment Details	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)
Pre-assignment Detail	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).

Arm/Group Title	Propess	Prostin E2
Arm/Group Description	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 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
Period Title: Overall Study
STARTED	100	100
COMPLETED	100	100
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Propess	Prostin E2	Total
Arm/Group Description	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 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.	Total of all reporting groups
Overall Participants	100	100	200
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	26 (4.3)	26.8 (5.1)	26.4 (4.7)
Sex: Female, Male (Count of Participants)
Female	100 100%	100 100%	200 100%
Male	0 0%	0 0%	0 0%
Body mass index (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	23 (2.7)	23.5 (3.5)	23.3 (3.1)
Parity (participants) [Number]
P0	44 44%	49 49%	93 46.5%
P1	20 20%	23 23%	43 21.5%
P2	20 20%	14 14%	34 17%
P3	11 11%	8 8%	19 9.5%
P4	3 3%	3 3%	6 3%
P5	2 2%	3 3%	5 2.5%
Gestational age (weeks) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [weeks]	40.6 (0.9)	40.4 (1.3)	40.5 (1.2)

Outcome Measures

1. Primary Outcome

Title	Induction to Delivery Interval
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Propess	Prostin E2
Arm/Group Description	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 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
Measure Participants	100	100
Mean (Standard Deviation) [hours]	22.3 (5.7)	21.2 (5.3)

2. Secondary Outcome

Title	Induction to Onset of Labor Interval
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Propess	Prostin E2
Arm/Group Description	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 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
Measure Participants	100	100
Mean (Standard Deviation) [hours]	18.8 (5.3)	17.7 (5.4)

3. Secondary Outcome

Title	Uterine Hyper-stimulation Rate
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Propess	Prostin E2
Arm/Group Description	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 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
Measure Participants	100	100
Number [participants]	1 1%	1 1%

4. Secondary Outcome

Title	Need for Syntocinon Augmentation
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Propess	Prostin E2
Arm/Group Description	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 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
Measure Participants	100	100
Number [participants]	5 5%	10 10%

5. Secondary Outcome

Title	Normal Vaginal Delivery Rate
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Propess	Prostin E2
Arm/Group Description	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 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
Measure Participants	100	100
Number [participants]	79 79%	85 85%

Adverse Events

Arm/Group Title	Propess		Prostin E2
Arm/Group Description	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 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
All Cause Mortality
	Propess		Prostin E2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Propess		Prostin E2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/100 (1%)		2/100 (2%)
Pregnancy, puerperium and perinatal conditions
Cord pH < 7.1	1/100 (1%)	1	2/100 (2%)	2
Other (Not Including Serious) Adverse Events
	Propess		Prostin E2
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/100 (14%)		13/100 (13%)
Pregnancy, puerperium and perinatal conditions
Maternal adverse outcomes	12/100 (12%)	12	13/100 (13%)	13
Apgar score < 7	0/100 (0%)	0	1/100 (1%)	1
Uterine tachysystole	2/100 (2%)	2	3/100 (3%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.