OPTION – OutPatienT InductiON: Labour induction in an outpatient setting - a multicentre randomized controlled trial

2023-507164-39-00 Therapeutic use (Phase IV) Ongoing, recruiting

Start 1 Dec 2021 · Status Ongoing, recruiting · 1 EU/EEA countries · 39 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Ongoing, recruiting
Participants planned 8,891
Countries 1
Sites 39

Induction of labour

The primary objective of the study is to show if outpatient induction is as safe and as effective as inpatient induction.

Key facts

Sponsor
Vaestra Goetalandsregionen
Participant type
Patients
Age range
18-64 years
Gender
Female
Therapeutic area
Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
Trial duration
1 Dec 2021 → ongoing
Decision date (initial)
2023-10-23
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes

External identifiers

EU CT number
2023-507164-39-00
EudraCT number
2020-000233-41

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

The primary objective of the study is to show if outpatient induction is as safe and as effective as inpatient induction.

Secondary objectives 7

  1. Efficacy and health care costs: Do the proportions of spontaneous and instrumental vaginal delivery (VD) in each group, VD within 24 and 48h from start of induction (VD24, VD48), and induction-to-delivery interval (hours), total hours in hospital, number of visits, telephone calls, need for ambulance transport, number of subsequent pregnancies, and mode of delivery in future pregnancies differ between the outpatient and inpatient group?
  2. Efficacy and health care costs: Is outpatient induction cost-effective compared with inpatient induction?
  3. Acceptability: Does outpatient induction differ from inpatient induction with respect to acceptability in patients, partners, and healthcare staff?
  4. Acceptability: How do women and their partner experience induction of labour at home i.e. outpatient induction?
  5. Acceptability: How do women and their partners experience induction of labour at the hospital i.e. inpatient induction?
  6. Acceptability: Does acceptability of induction of labour differ between women and partners in the outpatient and inpatient groups?
  7. Acceptability: How does medical health staff experience outpatient induction?

Conditions and MedDRA coding

Induction of labour

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

  1. Based on medical history: women 18-45 years old
  2. Based on medical history: able to communicate with the hospital
  3. Based on medical history: uncomplicated live singleton pregnancy
  4. Based on medical history: pregnancy week ≥37+0 to 41+6 according to crown rump length (CRL) or biparietal diameter (BPD<55 mm) at first or second trimester ultrasound
  5. Based on medical history: Stable cephalic presentation
  6. Based on clinical examination before start of induction including Leopold´s manoeuvres, digital cervical exam, abdominal ultrasound, blood pressure and CTG scan, if indicated temperature: Stable cephalic presentation.
  7. Based on clinical examination before start of induction including Leopold´s manoeuvres, digital cervical exam, abdominal ultrasound, blood pressure and CTG scan, if indicated temperature: Bishop score <6
  8. Based on clinical examination before start of induction including Leopold´s manoeuvres, digital cervical exam, abdominal ultrasound, blood pressure and CTG scan, if indicated temperature: CTG classified as normal according to the antepartal Swedish Society of Obstetrics and Gynaecology (Svensk Förening för Obstetrik och Gynekologi, SFOG) criteria (www.ctgutbildning.se)
  9. Based on observation the first 45 min after start of induction: in case of induction with catheter method: CTG classified as normal according to the antepartal Swedish Society of Obstetrics and Gynaecology (Svensk Förening för Obstetrik och Gynekologi, SFOG) criteria (www.ctgutbildning.se)
  10. Based on medical history: Able to reach the hospital in a reasonable time, at the discretion of the investigator with a maximum of 60 min as a benchmark

Exclusion criteria 20

  1. Based on medical history: previous uterine surgery with uterine scar, e.g. caesarean section or myomectomy
  2. Based on medical history: Known small for gestational age (SGA) defined as <2 standard deviations according to Marsal et al or intrauterine growth restriction (IUGR)
  3. Based on medical history: known allergy to any of the components of the balloon catheter or Angusta® (for the respective method only)
  4. Based on clinical examination before start of induction including Leopold´s manoeuvres, digital cervical exam, abdominal ultrasound, blood pressure and CTG scan, if indicated temperature: If the criteria outlined below are not met in their respective situation, the patient shall be excluded from the study: 1) In case of late term ≥41+0 to 41+6 weeks abdominal ultrasound will be performed and mean abdominal diameter (MAD) must be ≥110 mm. In case MAD <110 mm, the foetal weight will be estimated to exclude SGA foetus defined as <2 standard deviations according to Marsal et al the patient should be excluded. 2) In case of dietary or metformin treated gestational diabetes foetal weight to be or have been estimated by abdominal ultrasound within the last three weeks before induction and the result needs to be within normal range. 3) In case of stable hypertension foetal weight needs to be estimated by abdominal ultrasound within the last two weeks before induction and showing no SGA/IUGR foetus. 4) In case of indication for induction being prolonged latent phase, maternal age, mild intrahepatic cholestasis, pelvic girdle pain, PROM or psychosocial, a normal fundal height measurement according to the Swedish reference curves must be normal. In case of not-normal fundal height measurement: foetal weight estimation must be performed and showing no SGA/IUGR. 5) For all other indications foetal weight is estimated by abdominal ultrasound at the discretion of the investigator.
  5. Based on clinical examination before start of induction including Leopold´s manoeuvres, digital cervical exam, abdominal ultrasound, blood pressure and CTG scan, if indicated temperature: Oligohydramniosis: deepest vertical pocket <20 mm or amniotic fluid index <50 mm
  6. Based on clinical examination before start of induction including Leopold´s manoeuvres, digital cervical exam, abdominal ultrasound, blood pressure and CTG scan, if indicated temperature: polyhydramniosis: amniotic fluid index >250 mm
  7. Based on clinical examination before start of induction including Leopold´s manoeuvres, digital cervical exam, abdominal ultrasound, blood pressure and CTG scan, if indicated temperature: maternal pyrexia ≥38°C
  8. Based on clinical examination before start of induction including Leopold´s manoeuvres, digital cervical exam, abdominal ultrasound, blood pressure and CTG scan, if indicated temperature: known low-lying placenta (less than 20 mm from internal os measured by ultrasound)
  9. Based on clinical examination before start of induction including Leopold´s manoeuvres, digital cervical exam, abdominal ultrasound, blood pressure and CTG scan, if indicated temperature: Regarding premature rupture of membranes (PROM): 1) PROM is exclusion criteria for catheter method 2) PROM is exclusion criteria for prostaglandin method if: 2.1) Time point for confirmed PROM with timepoint for PROM as indicated by the woman >48 hours. 2.2) Known colonisation with group B streptococci or previous pregnancy complication linked to group B streptococci
  10. Based on medical history: pregestational (diagnosis before pregnancy or before gestational week 25) or insulin treated gestational diabetes
  11. Based on observation the first 45 min after start of induction: any adverse events within the first 45 min after start of induction, e.g. heavy bleeding, pain, PROM in case PROM was not indication for induction of labour
  12. Based on observation the first 45 min after start of induction: start of contractions
  13. Based on medical history: dietary or metformin treated gestational diabetes with small or large for gestational age foetus
  14. Based on medical history: preeclampsia or instable hypertensive disease
  15. Based on medical history: Intrahepatic cholestasis with serum bile acids ≥40 µmol/L
  16. Based on medical history: intrauterine foetal death (IUFD) in previous pregnancy
  17. Based on medical history: known foetal malformations or other foetal condition affecting the delivery or immediate care of the new-born
  18. Based on medical history: congenital uterine malformation which may affect safety
  19. Based on medical history: other condition requiring inpatient care, e.g. delivery within 60 min from arriving at the hospital in previous pregnancy
  20. Based on clinical examination before start of induction including Leopold´s manoeuvres, digital cervical exam, abdominal ultrasound, blood pressure and CTG scan, if indicated temperature: • Small for gestational age (SGA) defined as <2 and in case of diabetes either large for gestational age (LGA) defined as >2 standard deviation according to Marsal et al or suspected growth acceleration.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

  1. Safety defined as a composite outcome of severe perinatal morbidity or mortality
  2. Efficacy defined as proportion of women with vaginal delivery

Secondary endpoints 5

  1. Pregnancy and delivery-related outcomes (including safety, e.g. mother admitted to the intensive care unit, post-partum bleeding >1000 ml, proportion of women delivered vaginally within 24 or 48 hours from start of induction as well as for the children, e.g. the different variables being part of the primary safety composite outcome will be studied individually in form of exploratory analyses). These secondary end points are descriptive and obtained via registry data.
  2. Woman and partner's experience of self-efficacy, health-related quality of life, pain catastrophizing, anxiety and depression; women and partners' experience of childhood experiences and levels of breastfeeding; women and partners' experience as per qualitative interviews
  3. Understanding of healthcare staff's experience of outpatient vs inpatient induction of low-risk pregnancies
  4. Cost-effectiveness
  5. Future pregnancy outcome

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Angusta 25 mikrogram tabletter

PRD4975258 · Product

Active substance
Misoprostol
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
200 µg microgram(s)
Max total dose
400 µg microgram(s)
Max treatment duration
2 Day(s)
Authorisation status
Authorised
ATC code
G02AD06 — -
Marketing authorisation
54486
MA holder
NORGINE B.V.
MA country
Sweden
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Vaestra Goetalandsregionen

39 Total trials 20 Recruiting 12 Ended
Academic / Non-commercial
Sponsor organisation
Vaestra Goetalandsregionen
Address
Regionens Hus
City
Vänersborg
Postcode
462 80
Country
Sweden

Scientific contact point

Organisation
Vaestra Goetalandsregionen
Contact name
Verena Sengpiel

Public contact point

Organisation
Vaestra Goetalandsregionen
Contact name
Verena Sengpiel

Locations

1 EU/EEA country · 39 investigational sites

By country

CountryMS statusPlanned subjectsSites
Sweden Ongoing, recruiting 8,891 39
Rest of world — 0 —

Investigational sites

Sweden

39 sites · Ongoing, recruiting
Region Gaevleborg
Gävle Hospital, women´s clinic, Lasarettsvägen 1, 80188 Gävle, Rektorsgatan 1, 802 50, Gavle
Region Halland
Department of Obstetrics and Gynecology, Träslövsv.68, 43200 Varberg, Traslovsvagen 68, 432 37, Varberg
Region Blekinge
Women´s clinic, Lasarettsvägen, 37185 Karlskrona, Blekinge Country Hospital, Blekinge, Lasarettsvagen, 371 85, Karlskrona
Soedersjukhuset AB
Clinical science and education KI SÖS, sjukhusbacken 10, 118 83 Stockholm, Sjukhusbacken 10, Hogalid, Stockholm
Region Vaesternorrland
Sundsvall Hospital, Lasarettsvagen 21, 856 43 Sundsvall, Women's Health Unit, Lasarettsvagen 21, 856 43, Sundsvall
Region Oerebro Laen
Örebro University Hospital, Södra Grev Rosengatan 1, 701 85 Örebro, Sodra Grev Rosengatan, 701 85, Orebro
Danderyds Sjukhus AB
BB Stockholm, Danderyd Hospital, Bäckenvägen 5, 182 88 Stockholm, Morbygardsvagen 88, 182 88, Danderyd
Region Vaesterbotten
Skellefteå Hospital, Lasarettsvägen 29D, 931 41 Skellefteå, Koksvagen 11, Alidhem, Umea
Region Vaesterbotten
Norrland University Hospital, Daniel Naezéns väg, 907 37 Umeå, Center for Obstetrics and Gynecology, Koksvagen 11, Alidhem, Umea
Region Vaestmanland
Västmanland Hospital, Sigtunagatan, 721 89 Västerås, Sigtunagatan, 721 89, Vasteras
Region Dalarna
Women´s clinic, Falu hospital, 791 82 Falun, Vasagatan 27, Falu Kristine, Falun
Sodra Alvsborg Hospital-Vastra Gotalandsregionen
Department for Gynecology and obstetrics, South Älvsborg Hospital, Brämhultsvägen 53, 510 82 Borås, Bramhultsvagen 53, Boras Gustav Adolf, Boras
Karolinska University Hospital
Karolinska University Hospital, K 68, 141 86 Huddinge, Halsovagen, Flemingsberg, Huddinge
Region Skane Helsingborg Hospital
Dept.of Obstetrics and Gynecology, Helsingborg Hospital,Charlotte Yhléns gata 10, 252 23 Helsingborg, Charlotte Yhlens Gata 10, Helsingborgs Maria, Helsingborg
Linkoping University Hospital Region Ostergotland
Dept. Of OB/GYN, University Hospital Linköping,SE-58185 Linköping, Universitetssjukhuset I Linkoping, 581 85, Linkoping
Malarsjukhuset Eskilstuna
Delivery department, Mälarsjukhuset Eskilstuna, Kungsvagen 42, 63349 Eskilstuna, Kungsvagen 42, Tunafors, Eskilstuna
Region Halland
Hallands hospital Halmstad, Lasarettsvägen, 301 85 Halmstad, Lasarettsvagen 1, 302 33, Halmstad
Vaesterviks Sjukhus Region Kalmar Laen
Västervik Hospital, Department of Womens health, Ostra Kyrkogatan 48, 593 33, Vastervik
Uppsala University Hospital
Department of Obstetrics and Gynecology, 751 85 Uppsala, Uppsala University Hospital, Akademiska Sjukhuset, 751 85, Uppsala
Danderyds Sjukhus AB
Department of Women's Health, Danderyd Hospital, 182 88 Stockholm, Morbygardsvagen 88, 182 88, Danderyd
Region Norrbotten
Sunderby Hospital, Sjukhusvägen 10, 971 80 Luleå, Department of Obstetrics and Gyneacology, Robertsviksgatan 7, Lulea Domkyrkofors., Lulea
Karolinska University Hospital
Medical Unit Pregnancy and Childbirth, Karolinska University Hospital Solna, 171 76 Stockholm, Eugeniavagen 3, 171 64, Solna
Region Joenkoepings Laen
Värnamo Hospital, Department of Obstetrics and Gynecology, Doktorsgatan 5, 331 56, Varnamo
Soedertalje Sjukhus AB
Södertälje Hospital, Rosenborgsgatan 10, 152 86 Södertälje, Rosenborgsgatan 6-10, Ostertalje, Sodertalje
NU Hospital Group-Vastra Gotalandsregionen
NÄL Hospital, Department of obstetrics and gynecology, Lärketorpsvägen, 461 73 Trollhättan, Larketorpsvagen, 461 85, Trollhattan
Region Joenkoepings Laen
Women´s clinic, Region Hospital Ryhov, Sjukhusgatan, 551 85 Jönköping, Lanssjukhuset Ryhov, Sjukhusgatan, Jonkoping
Region Skane Skanes Universitetssjukhus
Skåne University Hospital Carl Bertil Laurellsg.9, 205 02 Malmö, St. Johns, Fritz Bauers Gata 5, Malmo
Skaraborg Hospital-Vastra Gotalandsregionen
Department of Obstetrics and Gynaecology, Central Hospital, Lövängsvägen, 541 50 Skövde, Lovangsvagen 1, 541 42, Skovde
Sahlgrenska University Hospital-Vastra Gotalandsregionen
Department of Obstetrics, Sahlgrenska University Hospital, Diagnosvägen 14, 416 85 Gothenburg, Diagnosvagen 11, Harlanda, Gothenburg
Region Joenkoepings Laen
Department of Obstetrics and Gynecology, Highland hospital Eksjö, Tallvägen, hus 11, 57581 Eksjö, Vastanagatan 9, 575 33, Eksjo
Region Vaermland
District Hospital Karlstad, Rosenborgsgatan 2, 651 85 Karlstad, Rosenborgsgatan 50, 652 33, Karlstad
Region Skane Skanes Universitetssjukhus
Skåne University Hospital, Entrégatan 7, 221 85 Lund, Entregatan 7, 222 42, Lund
Region Stockholm – SLSO
Visby Hospital, Dep. of Obstetrics and Gynecology, St. Göransgatan 5, 62155 Visby, Solnavagen 1 E, S:t Matteus, Stockholm
Vrinnevisjukhuset I Norrkoeping Region Oestergoetland
Maternity ward, Vrinnevi Hospital, Gamla Övägen 25, 603 79 Norrköping, S Borg, Gamla Ovagen 25, Norrkoping
Region Halland
Department of Obstetrics and Gynecology, Träslövsv.68, 43200 Varberg, Traslovsvagen 68, 432 37, Varberg
Region Kronoberg
Växjö Hospital, Strandvägen 8, 352 34 Växjö, Women's clinic, Nygatan 20, Vaxjo Stads- Och Domkyrkofors., Vaxjo
Region Skane Kristianstad Central Hospital
Kristianstad Central Hospital, J A Hedlundsväg 5, 291 33 Kristianstad, J A Hedlunds Vag 5, Kristianstads Heliga Trefaldighet, Kristianstad
Region Soermland
Gynecology department, Olrogs väg 1, 611 39 Nyköping, Nyköping Hospital, Nyköping, Repslagaregatan 19, 611 32, Nykoping
Region Jaemtland Haerjedalen
Women's Clinic, Östersunds Sjukhus, 831 83 Östersund, Kyrkgatan 12, 831 50, Ostersund

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Sweden 2021-12-01 2021-12-01

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 21 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol_2023-507164-39-00_SM_CLEAN 15
Protocol (for publication) D1_Protocol_CIP_SM_5_v15_2023-507164-39-00_public 15
Recruitment arrangements (for publication) K1_ Rekryteringsforfarande_2023-507164-39-00 1
Recruitment arrangements (for publication) K1_ Rekryteringsmaterial_Affisch_2023-507164-39-00 2
Recruitment arrangements (for publication) K1_ Rekryteringsmaterial_Infobroschyr_2023-507164-39-00 2
Recruitment arrangements (for publication) K1_ Rekryteringsmaterial_Powerpoint_Vantrum_2023-507164-39-00 1
Recruitment arrangements (for publication) K1_ Rekryteringsmaterial_Rollup_2023-507164-39-00 1
Recruitment arrangements (for publication) K1_Rekryteringsmaterial_kallelse_2023-507164-39-00 1
Recruitment arrangements (for publication) K1_Rekryteringsmaterial_OPTION-hemsida_2023-507164-39-00 1
Recruitment arrangements (for publication) K1_Rekryteringsmaterial_text_social_media_2023-507164-39-00 1
Subject information and informed consent form (for publication) K2_Forsokspersonsinformation och samtycke_2023-507164-39-00_Kvinnan kvalitativ_SM_CLEAN 2
Subject information and informed consent form (for publication) K2_Forsokspersonsinformation och samtycke_2023-507164-39-00_Kvinnan RCT_SM_CLEAN 5
Subject information and informed consent form (for publication) K2_Forsokspersonsinformation och samtycke_2023-507164-39-00_Partner RCT_SM_CLEAN 3
Subject information and informed consent form (for publication) K2_Forsokspersonsinformation och samtycke_2023-507164-39-00_Partnern kvalitativ_SM_CLEAN 2
Subject information and informed consent form (for publication) K2_Forsokspersonsinformation och samtycke_2023-507164-39-00_Personal kvalitativ_SM_CLEAN 2
Subject information and informed consent form (for publication) K2_Patientinfo engelska induktion Foley_clean 1
Subject information and informed consent form (for publication) K2_Patientinformation om induktion med Foley_clean 1
Subject information and informed consent form (for publication) K2_Patientinformation om induktion med lakemedel Angusta_ickePROM 2
Subject information and informed consent form (for publication) K2_Patientinformation om induktion med lakemedel Angusta_PROM 2
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_Angusta 1
Synopsis of the protocol (for publication) D1_Protocol_synopsis_SE_2023-507164-39-00 N/A

Application history

6 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2023-10-13 Sweden Acceptable
2023-10-23
 2023-10-23
2 SUBSTANTIAL MODIFICATION SM-1 2023-11-17 Sweden Acceptable
2023-12-20
 2024-01-16
3 SUBSTANTIAL MODIFICATION SM-2 2024-09-23 Sweden Acceptable 2024-10-30
4 SUBSTANTIAL MODIFICATION SM-3 2025-04-28 Sweden Acceptable
2025-07-08
 2025-07-09
5 NON SUBSTANTIAL MODIFICATION NSM-1 2025-07-10 Sweden 2025-07-10
6 SUBSTANTIAL MODIFICATION SM-5 2026-01-08 Sweden Acceptable
2026-02-16
 2026-02-18

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