Intravaginal APL202 versus dinoprostone in the induction of labour in nulliparous subjects
| ISRCTN | ISRCTN27617624 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27617624 |
| Secondary identifying numbers | APL202-001 |
- Submission date
- 15/01/2010
- Registration date
- 15/01/2010
- Last edited
- 19/01/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Ms Rebecca Scoble
Scientific
Scientific
Alliance Pharmaceuticals Ltd
Avonbridge House
Bath Road
Chippenham
SN15 2BB
United Kingdom
| medinfo@alliancepharma.co.uk |
Study information
| Study design | Randomised open comparative non-inferiority study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | A randomised open comparision of intravaginal APL202 (25 or 50 µg) followed by 25 µg after 4 and 8 hours versus 3 mg of dinoprostone as a vaginal tablet followed by 3 mg after 6 hours in the induction of labour in nulliparous subjects |
| Study hypothesis | The objective of study APL202-001 was to determine the safety and efficacy of APL202 in the induction of labour of nulliparous subjects compared with the standard agent currently used for cervical ripening. The trial was previously registered at Pharmaceutical Industry Clinical Trials Database (ABPI/CMR) - https://www.cmrinteract.com/clintrial/default.htm. |
| Ethics approval(s) | Huntingdon Research Ethics Committee approved on the 12th November 2004 (ref: 04/Q0104/94) |
| Condition | Induction of labour - nulliparous subjects only |
| Intervention | This was a randomised, open, comparative, non-inferiority study. Nulliparous subjects were allocated to one of two groups according to their Bishop score values and then randomised to one of two treatments. Subjects with Bishop score values of less than or equal to 4 were allocated to Group 1 and randomised to receive one of the two treatments, APL202 or dinoprostone, as follows: 1. APL202 50 µg intravaginally followed by 25 µg intravaginally after 4 and 8 hours 2. Dinoprostone 3 mg intravaginally followed by 3 mg intravaginally after 6 hours Subjects with Bishop score values less than 9 and greater than or equal to 5 were allocated to Group 2 and randomised to received one of the two treatments, APL202 or dinoprostone, as follows: 1. APL202 25 µg intravaginally followed by 25 µg intravaginally after 4 and 8 hours 2. Dinoprostone 3 mg intravaginally followed by 3 mg intravaginally after 6 hours The statistical section of the APL202-001 protocol was amended during the course of the study to note that a two-sided analysis would be performed, in line with revised guidelines from the EMEA [Guideline on the choice of the non-inferiority margin, EMEA]. Subjects were randomised equally to each treatment with 506 subjects scheduled to be recruited in conjunction with the same number of subjects in a parallel study APL202-002 (506 were due to be randomised to each treatment). However, a decision was made in 2006 with the agreement of the ethics and regulatory authorities to pool the data from this study and study APL202-002. This meant that a combined total of 622 subjects, with not more than two-thirds and not less than one-third from either study, were required to be enrolled. Scientific Contact Details - Lead Principal Investigator: Mr Andrew Loughney MB BS, B Med Sci, PhD, MRCOG Consultant Obstetrician and Head of Obstetrics Women's Services Royal Victoria Infirmary Richardson Road Newcastle upon Tyne, NE1 4LP United Kingdom |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | APL202, dinoprostone |
| Primary outcome measure | Number of vaginal deliveries within 24 hours of the start of induction |
| Secondary outcome measures | 1. Number of vaginal deliveries within 12 hours of the start of induction 2. Number of caesarean section deliveries 3. Mean induction-delivery interval 4. Distribution of induction-delivery interval 5. Oxytocin augmentation requirement 6. Number of instrument-assisted vaginal deliveries 7. Incidence and mean duration of tachysystole 8. Uterine hyperstimulation with fetal heart rate changes 9. Pyrexia during labour 10. Serious neonatal morbidity or perinatal death 11. Serious maternal morbidity or death Measured at differing timepoints prior to the discharge of the patients from the hospital after the delivery of the baby. |
| Overall study start date | 06/01/2005 |
| Overall study end date | 28/02/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 622 participants |
| Participant inclusion criteria | 1. Subjects, aged 18 years or over, having at least one previous term pregnancy suitable for induction of labour with prostaglandin cervical ripening agents 2. Pregnancy duration of at least 37 weeks 3. Subjects with an unfavourable cervix defined as a Bishop Score of less than 9 4. Signed informed consent |
| Participant exclusion criteria | 1. Subjects requiring insulin to control their diabetes. Subjects with controlled Type II or gestational diabetes that did not require insulin could be included. 2. Subjects with a multiple pregnancy 3. Subjects in whom oxytocic drugs were generally contraindicated or where prolonged contractions of the uterus were considered inappropriate, i.e.: 3.1. History of caesarean section or major uterine surgery 3.2. Cephalopelvic disproportion 3.3. Foetal malpresentation 3.4. Clinical suspicion or definite evidence of pre-existing foetal distress 4. Subjects with an intercurrent vaginal, systemic or ascending infection 5. Subjects with clinical suspicion or definite evidence of placenta praevia or unexplained vaginal bleeding during their pregnancy. Occasional spotting, considered by the Investigator to be of no clinical significance concerning the use of cervical ripening agents and having a reasonable explanation (e.g. cervical ectropion, cervical polyps), was not a reason for exclusion. 6. Subjects with active cardiac, pulmonary, renal or hepatic disease 7. Subjects with abruptio placenta 8. Subjects with ruptured membranes 9. Subjects with a known allergy to prostaglandins or other constituents of the tablets 10. Subjects with any contraindication to vaginal delivery (e.g., active genital herpes) |
| Recruitment start date | 06/01/2005 |
| Recruitment end date | 28/02/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Alliance Pharmaceuticals Ltd
Chippenham
SN15 2BB
United Kingdom
SN15 2BB
United Kingdom
Sponsor information
Alliance Pharmaceuticals Ltd (UK)
Industry
Industry
Avonbridge House
Bath Road
Chippenham
SN15 2BB
United Kingdom
| Phone | +44 (0)1249 466966 |
|---|---|
| info@alliancepharma.co.uk | |
| Website | http://www.alliancepharma.co.uk |
"ROR" |
https://ror.org/001zd1d95 |
Funders
Funder type
Industry
Alliance Pharmaceuticals Ltd (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2008 | Yes | No |
