Labor Pain
Conditions
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).
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.
Interventions
DRUGPropess
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.
DRUGProstin 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.
Sponsors
North West Armed Forces Hospital
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Induction to Delivery Interval | 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| Induction to Onset of Labor Interval | 24 hours |
| Uterine Hyper-stimulation Rate | 24 hours |
| Need for Syntocinon Augmentation | 24 hours |
| Normal Vaginal Delivery Rate | 24 hours |
Countries
Saudi Arabia
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 details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 100 |
| Prostin E2 PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository. | 100 |
| Total | 200 |
Baseline characteristics
| Characteristic | Prostin E2 | Total | Propess |
|---|---|---|---|
| Age, Continuous | 26.8 years STANDARD_DEVIATION 5.1 | 26.4 years STANDARD_DEVIATION 4.7 | 26 years STANDARD_DEVIATION 4.3 |
| Body mass index | 23.5 kg/m^2 STANDARD_DEVIATION 3.5 | 23.3 kg/m^2 STANDARD_DEVIATION 3.1 | 23 kg/m^2 STANDARD_DEVIATION 2.7 |
| Gestational age | 40.4 weeks STANDARD_DEVIATION 1.3 | 40.5 weeks STANDARD_DEVIATION 1.2 | 40.6 weeks STANDARD_DEVIATION 0.9 |
| Parity P0 | 49 participants | 93 participants | 44 participants |
| Parity P1 | 23 participants | 43 participants | 20 participants |
| Parity P2 | 14 participants | 34 participants | 20 participants |
| Parity P3 | 8 participants | 19 participants | 11 participants |
| Parity P4 | 3 participants | 6 participants | 3 participants |
| Parity P5 | 3 participants | 5 participants | 2 participants |
| Sex: Female, Male Female | 100 Participants | 200 Participants | 100 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 14 / 100 | 13 / 100 |
| serious Total, serious adverse events | 1 / 100 | 2 / 100 |
Outcome results
Primary
Induction to Delivery Interval
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Propess | Induction to Delivery Interval | 22.3 hours | Standard Deviation 5.7 |
| Prostin E2 | Induction to Delivery Interval | 21.2 hours | Standard Deviation 5.3 |
Secondary
Induction to Onset of Labor Interval
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Propess | Induction to Onset of Labor Interval | 18.8 hours | Standard Deviation 5.3 |
| Prostin E2 | Induction to Onset of Labor Interval | 17.7 hours | Standard Deviation 5.4 |
Secondary
Need for Syntocinon Augmentation
Time frame: 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Propess | Need for Syntocinon Augmentation | 5 participants |
| Prostin E2 | Need for Syntocinon Augmentation | 10 participants |
Secondary
Normal Vaginal Delivery Rate
Time frame: 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Propess | Normal Vaginal Delivery Rate | 79 participants |
| Prostin E2 | Normal Vaginal Delivery Rate | 85 participants |
Secondary
Uterine Hyper-stimulation Rate
Time frame: 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Propess | Uterine Hyper-stimulation Rate | 1 participants |
| Prostin E2 | Uterine Hyper-stimulation Rate | 1 participants |