## Protocol Section
### Identification Module
**NCT ID:** NCT02794779

**Acronym:** MODCL

**Brief Title:** Minimum Oxytocin Dose for Cesarean During Labor: Adaptative Clinical Trial

**Official Title:** Minimum Oxytocin Dose for Cesarean During Labor: Adaptative Clinical Trial

#### Organization Study ID Info
**ID:** anestesiatccthiago1416
#### Organization
**Class:** OTHER
**Full Name:** Brasilia University Hospital
### Status Module
#### Completion Date
**Date:** 2017-12

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2017-01-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2017-01-30

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2017-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2016-07

**Status Verified Date:** 2017-01

#### Study First Post Date
**Date:** 2016-06-09
**Type:** ESTIMATED
**Study First Submit Date:** 2016-06-04
**Study First Submit QC Date:** 2016-06-08
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Brasilia University Hospital

#### Responsible Party

**Investigator Affiliation:** Brasilia University Hospital

**Investigator Full Name:** Gabriel Magalhaes Nunes Guimaraes

**Investigator Title:** MD, MSc

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Introduction: postpartum hemorrage is a leading cause of death after cesarean sections in Brazil. Oxytocin is the main drug for both prophylaxis and threatment of postpartum hemorrage because uterine atony is the most prevalent cause. Both excessive and too low oxytocin doses threaten the life of women.

Objective: to determine the minimum effective dose of oxytocin for cesareans during labor.

Method: adaptative clinical trial using a modified up and down method of two sequential groups: rule of three and continuous infusion. Allocation in rule of three or continuous infusion will be random and masked for patients and anesthesiologists. The minimum effective dose will be the effective dose for 90% of success (ED90 for preventing uterine atony).

### Conditions Module

**Conditions:**

- Cesarean Section During Labor

**Keywords:**

- cesarean section

- labor

- oxytocin

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 64

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Intravenous bolus infusion of oxytocin 3UI followed by re-asessment of uterine tone by obstetrician after 3 minutes. Infusion stops when uterine tone is adequate and is repeated if inadequate to the maximum of 9UI (3 bolus infusions). If uretine tone is inadequate after 9UI then other methods for preventing bleeding will be used.

**Intervention Names:**

- Drug: Oxytocin

**Label:** Rule of three

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Continuous infusion of variable rate if 0,4 UI of oxytocin until obstetrician determines that uterine tone is adequate.

**Intervention Names:**

- Drug: Oxytocin

**Label:** Continuous infusion

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Continuous infusion

- Rule of three

**Description:** Intravenous bolus infusion of oxytocin 3UI followed by re-asessment of uterine tone by obstetrician after 3 minutes. Infusion stops when uterine tone is adequate and is repeated if inadequate to the maximum of 9UI (3 bolus infusions). If uretine tone is inadequate after 9UI then other methods for preventing bleeding will be used.

**Name:** Oxytocin

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Minumum oxytocin dose for preventing uterine atony in 90% of cesareans.

**Measure:** Oxytocin dose

**Time Frame:** 10 minutes

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Cesarean delivery during labor.
* Spinal anesthesia

Exclusion Criteria:

* Change of anesthesia

**Maximum Age:** 130 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** gabrielmng@gmail.com

**Name:** Gabriel MN Guimaraes, MD, MSc

**Phone:** +5561996455997

**Role:** CONTACT

**Contact 2:**

**Email:** helgabgs@gmail.com

**Name:** Helga BG Silva, MD, PhD

**Phone:** 5561991755997

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Brasilia

**Contacts:**

***Contact 1:***

- **Email:** gabrielmng@gmail.com

- **Name:** Gabriel MN Guimaraes, MD MsC

- **Phone:** 6196455997

- **Role:** CONTACT

**Country:** Brazil

**Facility:** Hospital Universitário de Brasília

**State:** Distrito Federal

**Status:** RECRUITING

**Zip:** 70000000

## Derived Section

### Intervention Browse Module - Ancestors

- ID: D000010120

- Term: Oxytocics

- ID: D000012102

- Term: Reproductive Control Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: Repr

- Name: Reproductive Control Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M13041

- Name: Oxytocin

- Relevance: HIGH

- As Found: Joint

### Intervention Browse Module - Meshes

- ID: D000010121

- Term: Oxytocin

### Misc Info Module

- Version Holder: 2024-05-24
