Controlled Cord Traction During Third Stage of Labor

13:08 EDT 31st October 2014 | BioPortfolio

Summary

Of the estimated number of 529,000 maternal deaths for the year 2000, 132,000 (25%) were caused by postpartum hemorrhage (PPH); 99% of these deaths occurred in low-income countries. Where maternal mortality is high and resources are limited, the introduction of low-cost, evidence-based practices for primary prevention of PPH is an urgent need. Controlled cord traction (CCT) is actively promoted in combination with prophylactic uterotonics for the prevention of PPH. While the administration of uterotonics has been proven effective, there is no evidence of CCT being beneficial or safe. The investigators propose this study to evaluate two primary questions:

1. In women having term, single vaginal deliveries in hospital settings, in whom the third stage is managed with prophylactic oxytocin, does CCT produce a clinically significant reduction in the incidence of postpartum blood lose?

2. In these women, does CCT produce a clinically significant increase in the incidence of severe complications, including uterine inversion or the need for subsequent surgical evacuation of retained placental tissues and membranes (curettage or manual removal)?

To answer these two questions we designed two arms randomized controlled trial.

Description

Subjects This study will be conducted in two Public Hospital from Montevideo, Uruguay. A total of 200 women (100 by group) will be recruited.

Description of the Study Design This will be a two-arm, randomized controlled clinical trial in which 200 women having a single vaginal delivery and receiving prophylactic oxytocin for the management of the third stage of labor at two public hospital in Montevideo will be allocated to one of two interventions: CCT or a "hands-off" policy. All outcomes will be measured before maternal discharge from the hospital. The primary outcome is postpartum blood loss.

Duration of the Study We estimate that we will need a total of 11 months to complete this study. Three months will be needed for preparation (installing data collection resources and training data collectors and birth attendants), and 6 months for recruitment, and two months for data analysis and preparation of reports and manuscripts.

Where Subjects Are/ Study Site and Populations The study will be conducted in two public hospitals from Montevideo, Uruguay. These are third level public hospitals supported by the University of the Republic, with a total of 9,900 deliveries per year.

Full Description of Risks There is no evidence to suggest that there were risks from this study to the women or the newborns, because it is not known if CCT is associated with serious complications in the mother. In all previous active management trials and in the two CCT trials, there were no reported cases of uterine inversion, and currently, CCT is the recommended standard of care during delivery. In theory, the most severe potential complication is uterine inversion, which can be a life-threatening condition if adequate care is not provided. However, this event is unlikely with the simultaneous use of uterotonics to assure a well contracted uterus and eventually, it can be successfully managed in hospital settings.

Benefits for Subjects and/or Society:

We do not expect a clinical and important benefit from this study at an individual level of the pregnant women. However, this study will provide useful information to evaluate one specific intervention recommended for the management of third stage of labor.

Inducement for Participants:

No monetary inducement will be offered to the participants.

Costs to Subjects: N/A

Statistical Analysis Before addressing the research question, descriptive statistics and summary graphics such as histograms will be prepared and examined for outcomes and demographic variables. All analyses addressing the study research questions will use the "intention to treat" principle, thus comparing the original intervention group to the original nonintervention group, even if individuals have withdrawn from the study or shifted to another group. The analysis plan and presentation of results will follow the recommendation of the CONSORT statement. In this study the primary outcome is continues (blood loss), therefore, median and inter-quartile ranges will be computed as part of descriptive data analysis to understand the distribution of the outcome variables and to assess the need of data transformation or adoption of nonparametric tests, including Mann-Whitney U tests. Means for the two groups will be compared by the two-sample t-test. A similar analysis will be performed for the duration (in minutes) of the third stage of labor.

Methods of Recruitment:

Enrollment will be done during and previous to women's labor at the maternity. Screening will start at the time of admission and when possible during prenatal care, and for those eligible women, a signed consent form will be required. Sealed envelopes opened just before delivery(at delivery guard) will be used to determine whether the woman should receive CCT or not. A random allocation scheme will be derived from a computer-generated list of numbers, with randomly permuted blocks.

Informed Consent Services directors will provide written authorization to participate in this study. Individual birth attendants will receive an information sheet describing the objectives of the study and including the name and phone number of the study coordinator. Birth attendants will also be invited to participate in the training workshops. Women will be invited to participate upon admission to the hospital (or during prenatal care when possible) and, if they agree to participate, will provide written informed consent to their birth attendant. The birth attendant will then be required to disclose to the patient all of the facts about the nature of the trial, interventions under comparison, the risks involved, available alternatives and their risk, and reasonable expectations for the treatment outcome. This study was submitted to the Institutional Review Board of the School of Medicine, University of Uruguay for approval and the Institutional Review Board of Tulane University . The PI and co-PI have attended training sessions on the protection of human subjects and have been certified by the Institutional Review Boards at their institutions. The coordinator and research assistant invited to participate in this study will be asked to complete an on-line training session on protection of human subjects.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Conditions

Postpartum Hemorrhage

Intervention

Controlled cord traction, No controlled cord traction

Location

Clinica's Hospital Manuel Quintela of the University of the Republic of Uruguay
Montevideo
Uruguay
11600

Status

Completed

Source

Universidad de la Republica

Results (where available)

View Results

Links

Clinical Trials [1152 Associated Clinical Trials listed on BioPortfolio]

Manual Therapy, Exercise and Traction for Patients With Cervical Radiculopathy: A RCT

To date, optimal strategies for the management of patients with Cervical Radiculopathy (CR) remain elusive. The purpose of this study was to compare the effects of manual therapy, exercise...

Active Versus Expectant Management of the Third Stage of Labor

The purpose of this study is to determine if giving oxytocin immediately after delivery causes less bleeding, transfusion needs and hastens delivery of placenta.

Traction Assisted Polypectomy of the Intestine

The purpose of the study is to verify if the ablation of lesions (polyps, adenomas) in the large (and small) intestine can be facilitated by using a traction on the lesions.

Skeletal Versus Cutaneous Traction For Treatment of Femur Fractures

The purpose of this study is to determine whether there are any differences in skeletal or cutaneous traction for the treatment of femur fractures.

A Study to Compare Multiple Doses Intravitreal Microplasmin for Treatment of Patients With Vitreomacular Traction (MIVI-IIt)

A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with vitreomacular traction.

PubMed Articles [8111 Associated PubMed Articles listed on BioPortfolio]

Usefulness of the thread-traction method in esophageal endoscopic submucosal dissection: a randomized controlled trial.

To assess the usefulness of the thread-traction method (TT method) in esophageal endoscopic submucosal dissection (ESD).

Hemorrhagic intramedullary hemangioblastoma of the cervical spinal cord presenting with acute-onset quadriparesis: Case report and review of the literature.

Context Hemangioblastomas of the spinal cord are uncommon vascular tumors. Patients commonly present with subtle neurologic findings that are thought to represent growth of the lesion over time. Hemor...

Dislocability of localization devices for nonpalpable breast lesions: experimental results.

Purpose. For accurate resection of nonpalpable malignant breast lesions with a tumor-free resection rim, an exact and stable wire localization is essential. We tested the resistance towards traction f...

Prospective clinical trial of traction device-assisted endoscopic submucosal dissection of large superficial colorectal tumors using the S-O clip.

Endoscopic submucosal dissection (ESD) allows en bloc resection of superficial colorectal tumors regardless of size. However, ESD is technically difficult, hazardous, and time consuming. New devices m...

A DNA-based molecular probe for optically reporting cellular traction forces.

We developed molecular tension probes (TPs) that report traction forces of adherent cells with high spatial resolution, can in principle be linked to virtually any surface, and obviate monitoring defo...

Medical and Biotech [MESH] Definitions

The pull on a limb or a part thereof. Skin traction (indirect traction) is applied by using a bandage to pull on the skin and fascia where light traction is required. Skeletal traction (direct traction), however, uses pins or wires inserted through bone and is attached to weights, pulleys, and ropes. (From Blauvelt & Nelson, A Manual of Orthopaedic Terminology, 5th ed)

Extraoral devices for applying force to the dentition in order to avoid some of the problems in anchorage control met with in intermaxillary traction and to apply force in directions not otherwise possible.

Removal of the fetus from the uterus or vagina at or near the end of pregnancy with a metal traction cup that is attached to the fetus' head. Negative pressure is applied and traction is made on a chain passed through the suction tube. (From Stedman, 26th ed & Dorland, 28th ed)

Pathological processes involving any of the BLOOD VESSELS feeding the SPINAL CORD, such as the anterior and paired posterior spinal arteries or their many branches. Disease processes may include ATHEROSCLEROSIS; EMBOLISM; and ARTERIOVENOUS MALFORMATIONS leading to ISCHEMIA or HEMORRHAGE into the spinal cord (hematomyelia).

A syndrome associated with traumatic injury to the cervical or upper thoracic regions of the spinal cord characterized by weakness in the arms with relative sparing of the legs and variable sensory loss. This condition is associated with ischemia, hemorrhage, or necrosis involving the central portions of the spinal cord. Corticospinal fibers destined for the legs are spared due to their more external location in the spinal cord. This clinical pattern may emerge during recovery from spinal shock. Deficits may be transient or permanent.

More From BioPortfolio on "Controlled Cord Traction During Third Stage of Labor"

Search BioPortfolio:
Loading
Advertisement

Relevant Topic

Women's Health
Latest News Clinical Trials Research Drugs Reports Corporate
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...

Advertisement