In-vitro Myometrial Contractility After Oxytocin Pre-exposure in Women With Advanced Maternal Age and Morbid Obesity

NCT01865669 | Completed

• 1 other identifier: 13-04
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Women with advanced maternal age and morbid obesity, have a higher incidence of labor induction/ augmentation and cesarean section (CS), and are at a greater risk for postpartum hemorrhage (PPH). Oxytocin is the first line drug in the treatment of PPH, however, oxytocin receptor (OTR) desensitization has been recognized in the context of prolonged labors secondary to either endogenous or exogenous oxytocin exposure. It is unknown if oxytocin desensitization specifically affects contractility in women with advanced maternal age and morbid obesity when compared to younger or normal weight populations. Further it is not known if the higher incidence of PPH seen in these women is due to poor uterine contractility and/or poor response to oxytocin. The investigators hypothesize that women with advanced maternal age and morbid obesity will exhibit poor myometrial contractility as compared to women that are younger and of normal body habitus, in both oxytocin pre-treated and untreated myometrium.

Conditions

Postpartum Hemorrhage

Keywords

Uterine contraction; Dose response; Oxytocin

Outcome Measures

Primary Outcomes (1)

• Motility index

  6-8 hours

Secondary Outcomes (3)

• Amplitude of contraction

  6-8 hours

• Integrated area under response curve (AUC)

  6-8 hours

• Frequency of contraction

  6-8 hours

Study Arms (2)

Control

NO INTERVENTION

A control sample from each patient (no oxytocin applied) will be measured concurrently with samples treated with varying concentrations of oxytocin.

Oxytocin

EXPERIMENTAL

Samples from each patient will be bathed in a solution containing varying concentrations of oxytocin.

Drug: Oxytocin

Interventions

Oxytocin DRUG

Oxytocin, 10-10mol/L to 10-5mol/L

Also known as: pitocin

Oxytocin

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who give written informed consent
• patients requiring elective primary or 1st repeat Cesarean section
• patients with gestational age 37-41 weeks
• non-labouring patients, not exposed to exogenous oxytocin
• Cesarean section under spinal anesthetic
• patients \<30 years of age with a normal pre-pregnancy BMI (20 and 24.9 kg/m2)
• patients ≥40 years of age with a normal pre-pregnancy BMI
• patients with a BMI≥40 kg/m2 and age \<30 years

You may not qualify if:

• patients who refuse to give written informed consent
• patients who require general anesthesia
• patients who have had more than one previous uterine surgery/CS
• patients with placental abnormalities (abruption, accreta, percreta)
• patients with bleeding disorders
• presence of any other risk factors for PPH

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

Related Publications (1)

• Luca AM, Carvalho JCA, Ramachandran N, Balki M. The effect of morbid obesity or advanced maternal age on oxytocin-induced myometrial contractions: an in vitro study. Can J Anaesth. 2020 Jul;67(7):836-846. doi: 10.1007/s12630-020-01615-6. Epub 2020 Mar 18.

  PMID: 32189217 DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Mrinalini Balki, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2013
• First Posted: May 31, 2013
• Study Start: May 1, 2013
• Primary Completion: June 13, 2017
• Study Completion: June 13, 2017
• Last Updated: February 6, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)