|
Welcome
|
|
30 July 2010
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| Intravaginal APL202 versus dinoprostone in the induction of labour in nulliparous subjects |
| ISRCTN | ISRCTN27617624 |
| ClinicalTrials.gov identifier | |
| Public title | Intravaginal APL202 versus dinoprostone in the induction of labour in nulliparous subjects |
| 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 |
| Acronym | N/A |
| Serial number at source | APL202-001 |
| 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 | Huntingdon Research Ethics Committee approved on the 12th November 2004 (ref: 04/Q0104/94) |
| Study design | Randomised open comparative non-inferiority study |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Induction of labour - nulliparous subjects only |
| Participants - 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 |
| Participants - 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) |
| Anticipated start date | 06/01/2005 |
| Anticipated end date | 28/02/2007 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 622 participants |
| Interventions |
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 |
| Primary outcome measure(s) | Number of vaginal deliveries within 24 hours of the start of induction |
| Secondary outcome measure(s) |
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. |
| Sources of funding | Alliance Pharmaceuticals Ltd (UK) |
| Trial website | |
| Publications | 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18715414 |
| Contact name | Ms Rebecca Scoble |
| Address |
Alliance Pharmaceuticals Ltd
Avonbridge House Bath Road |
| City/town | Chippenham |
| Zip/Postcode | SN15 2BB |
| Country | United Kingdom |
| medinfo@alliancepharma.co.uk | |
| Sponsor | Alliance Pharmaceuticals Ltd (UK) |
| Address |
Avonbridge House
Bath Road |
| City/town | Chippenham |
| Zip/Postcode | SN15 2BB |
| Country | United Kingdom |
| Tel | +44 (0)1249 466966 |
| Fax | +44 (0)1249 466977 |
| info@alliancepharma.co.uk | |
| Sponsor website: | http://www.alliancepharma.co.uk |
| Date applied | 15/01/2010 |
| Last edited | 19/01/2010 |
| Date ISRCTN assigned | 15/01/2010 |
|
|
|
|
|
| © 2010 ISRCTN unless otherwise stated. | |
|
|
|
|