MOTHER trial: Efficacy and safety of low-dose intrathecal morphine following planned caesarean section

2024-518678-16-00 Therapeutic use (Phase IV) Ongoing, recruiting

Start 8 Jul 2025 · Status Ongoing, recruiting · 1 EU/EEA countries · 9 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Ongoing, recruiting
Participants planned 1,312
Countries 1
Sites 9

Caesarean section, acute postoperative pain

The aim of this trial is to evaluate analgesic efficacy and safety (patients and neonates) associated with addition of low-dose (80 µg) intrathecal morphine versus placebo to standard multimodal postoperative pain management in patients undergoing elective caesarean section.

Key facts

Sponsor
Region Sjaelland
Participant type
Patients
Age range
18-64 years
Gender
Female
Therapeutic area
Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
Trial duration
8 Jul 2025 → ongoing
Decision date (initial)
2025-05-05
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes
Funding sources
Danmarks Frie Forskningsfond (Indepedent Research Fund Denmark) · Department of Anaesthesiology, Zealand University Hospital · Hørslevfonden · Region Zealand

External identifiers

EU CT number
2024-518678-16-00
ClinicalTrials.gov
NCT06797973

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy

The aim of this trial is to evaluate analgesic efficacy and safety (patients and neonates) associated with addition of low-dose (80 µg) intrathecal morphine versus placebo to standard multimodal postoperative pain management in patients undergoing elective caesarean section.

Conditions and MedDRA coding

Caesarean section, acute postoperative pain

VersionLevelCodeTermSystem organ class
25.0 LLT 10087028 Elective caesarean section 100000004848
20.0 PT 10006924 Caesarean section 100000004865
25.0 LLT 10087055 Planned caesarean section 100000004848

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

  1. Patients ≥ 18 years
  2. Singleton pregnancy
  3. Scheduled for elective caesarean section performed under spinal anaesthesia
  4. Written informed consent

Exclusion criteria 5

  1. Allergy to or contraindications towards trial medication
  2. Patients planned for postoperative epidural due to expected difficult postoperative pain management
  3. Patients planned for combined spinal-epidural as primary anaesthesia
  4. Inability to understand and read Danish
  5. Previous inclusion in the trial

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

  1. Level of pain when mobilising from supine to sitting position within 24 hours: Level of pain when mobilising from supine to sitting position within 24 hours
  2. Maternal and neonatal safety: Binary composite outcome consisting of 1) participants with respiratory depression 2) participants with severe nausea/vomiting within 24 hours 3) neonatal admission within 48 hours 4) hospitalisation of participant or neonate within 7 days after discharge and 5) death of either participant or neonate within 7 days

Secondary endpoints 5

  1. Opioid consumption within 24 hours
  2. Morphine associated adverse events within 24 hours: Vomiting, nausea, dizziness, pruritus and urinary retention
  3. Obstetric quality of recovery score at 24 hours
  4. Participants satisfaction with postoperative pain-treatment during the first 24 hours
  5. Established breastfeeding at 30 days

Investigational products

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

Test 1

Morphine Hydrochloride

SUB14596MIG · Substance

Active substance
Morphine Hydrochloride
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRATHECAL USE
Max daily dose
80 µg microgram(s)
Max total dose
80 µg microgram(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Placebo 1

Sodium chloride 9 mg/ml (solution for injection)

N/A · Product

Other product name
N/A
Pharmaceutical form
N/A
ATC code
N/A — N/A
Marketing authorisation
N/A
MA holder
N/A
MA country
Iceland
Paediatric formulation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Sjaelland

14 Total trials 7 Recruiting 2 Ended
Academic / Non-commercial
Sponsor organisation
Region Sjaelland
Address
Sygehusvej 10
City
Roskilde
Postcode
4000
Country
Denmark

Scientific contact point

Organisation
Region Sjaelland
Contact name
Anne Juul Wikkelsø

Public contact point

Organisation
Region Sjaelland
Contact name
Anne Juul Wikkelsø

Third parties 1

OrganisationCity, countryDuties
Frederiksberg Hospital
ORG-100028217
 Frederiksberg, Denmark On site monitoring

Locations

1 EU/EEA country · 9 investigational sites

By country

CountryMS statusPlanned subjectsSites
Denmark Ongoing, recruiting 1,312 9
Rest of world — 0 —

Investigational sites

Denmark

9 sites · Ongoing, recruiting
Region Midtjylland
Department of Anaesthesia, Sundvej 30, 8700, Horsens
Aarhus University Hospital
Department of Anaesthesia, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Lillebaelt Hospital
Department of Anaesthesia, Sygehusvej 24, 6000, Kolding
Region Sjaelland
Department of Anaesthesia, Sygehusvej 10, 4000, Roskilde
Rigshospitalet
Department of Anaesthesia, Blegdamsvej 9, 2100, Copenhagen Oe
Region Hovedstaden
Department of Anaesthesia, Kettegaard Alle 30, 2650, Hvidovre
Region Hovedstaden
Department of Anaesthesia, Kongens Vaenge 2, 3400, Hilleroed
Odense University Hospital
Department of Anaesthesia, J B Winsloews Vej 4, 5000, Odense C
Region Hovedstaden
Department of Anaesthesia, Herlev Ringvej 75, 2730, Herlev

Country notifications

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

Country Trial startTrial end Recruitment startRecruitment end Early termination
Denmark 2025-07-08 2025-07-15

Results and documents

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

Documents 11 files

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

TypeTitleVersion
Protocol (for publication) D1_Protocol MOTHER trial_2024-518678-16-00 1.3
Protocol (for publication) D1_Protocol MOTHER trial_2024-518678-16-00_TC 1.3
Protocol (for publication) D4_questionnaires_DA_2024-518678-16-00 1.1
Protocol (for publication) D4_questionnaires_DA_2024-518678-16-00_TC 1.1
Recruitment arrangements (for publication) K1_Recruitment and informed consent procedure_2024-518678-16-00 1.2
Recruitment arrangements (for publication) K1_Recruitment and informed consent procedure_2024-518678-16-00_TC 1.2
Recruitment arrangements (for publication) K2_Infographic_2024-518678-16-00 1
Subject information and informed consent form (for publication) L1_SIS and ICF_DA_2024-518678-16-00 1.3
Subject information and informed consent form (for publication) L1_SIS and ICF_DA_2024-518678-16-00_TC 1.3
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC morphine_DA_2024-518678-16-00 1
Synopsis of the protocol (for publication) D1_Protocol synopsis_EN_2024-518678-16-00 1

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-01-30 Denmark Acceptable
2025-04-09
 2025-05-05
2 SUBSTANTIAL MODIFICATION SM-1 2025-12-09 Denmark Acceptable
2026-02-06
 2026-02-06