A Phase 3 interventional study of Propess and Prostin E2 in Labor Pain, sponsored by Ain Shams University. Completed at 1 site in Saudi Arabia. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2014-02-06.
Sponsored by Ain Shams University · Phase 3, Interventional, and Treatment
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).
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.
397 studies on the registry are indexed under Labor Pain; 67 are open to participants now.
This study's enrollment of 200 is above the median of 100 across 327 interventional studies indexed under Labor Pain.
Browse Labor Pain studies →Ain Shams University is the lead sponsor of 1,879 studies on the registry; 424 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
Drug: Prostin E2
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.
Also known as: Intravaginal PGE2 insert
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.
Also known as: Dinoprostone (PGE2)vaginal tablets.
Induction to Delivery Interval
Time frame: 24 hours
Induction to Onset of Labor Interval
Time frame: 24 hours
Uterine Hyper-stimulation Rate
Time frame: 24 hours
Need for Syntocinon Augmentation
Time frame: 24 hours
Normal Vaginal Delivery Rate
Time frame: 24 hours
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)
| Milestone | Propess | Prostin E2 |
|---|---|---|
| Started | 100 | 100 |
| Completed | 100 | 100 |
| Not completed | 0 | 0 |
| hours | Propess | Prostin E2 |
|---|---|---|
| Induction to Delivery Interval | 22.3 ± 5.7 | 21.2 ± 5.3 |
| hours | Propess | Prostin E2 |
|---|---|---|
| Induction to Onset of Labor Interval | 18.8 ± 5.3 | 17.7 ± 5.4 |
| participants | Propess | Prostin E2 |
|---|---|---|
| Uterine Hyper-stimulation Rate | 1 | 1 |
| participants | Propess | Prostin E2 |
|---|---|---|
| Need for Syntocinon Augmentation | 5 | 10 |
| participants | Propess | Prostin E2 |
|---|---|---|
| Normal Vaginal Delivery Rate | 79 | 85 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Propess | — | 1/100 (1%) | 14/100 (14%) |
| Prostin E2 | — | 2/100 (2%) | 13/100 (13%) |
| Event | Propess | Prostin E2 |
|---|---|---|
| Cord pH < 7.1Pregnancy, puerperium and perinatal conditions | 1/100 | 2/100 |
| Event | Propess | Prostin E2 |
|---|---|---|
| Maternal adverse outcomesPregnancy, puerperium and perinatal conditions | 12/100 | 13/100 |
| Uterine tachysystolePregnancy, puerperium and perinatal conditions | 2/100 | 3/100 |
| Apgar score < 7Pregnancy, puerperium and perinatal conditions | 0/100 | 1/100 |
| Age, Continuous(years) | Propess | Prostin E2 | Total |
|---|---|---|---|
| Mean | 26 ± 4.3 | 26.8 ± 5.1 | 26.4 ± 4.7 |
| Sex: Female, Male(Participants) | Propess | Prostin E2 | Total |
|---|---|---|---|
| Female | 100 | 100 | 200 |
| Male | 0 | 0 | 0 |
| Body mass index(kg/m^2) | Propess | Prostin E2 | Total |
|---|---|---|---|
| Mean | 23 ± 2.7 | 23.5 ± 3.5 | 23.3 ± 3.1 |
| Parity(participants) | Propess | Prostin E2 | Total |
|---|---|---|---|
| P0 | 44 | 49 | 93 |
| P1 | 20 | 23 | 43 |
| P2 | 20 | 14 | 34 |
| P3 | 11 | 8 | 19 |
| P4 | 3 | 3 | 6 |
| P5 | 2 | 3 | 5 |
| Gestational age(weeks) | Propess | Prostin E2 | Total |
|---|---|---|---|
| Mean | 40.6 ± 0.9 | 40.4 ± 1.3 | 40.5 ± 1.2 |
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Ain Shams University