Trials / Completed
CompletedNCT02659605
Cord Clamping Level Above or Below Mother's Perineum
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 103 (actual)
- Sponsor
- The University of Texas Health Science Center, Houston · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine if delayed cord clamping above the perineum has an effect on neonatal hematocrit when compared to delayed cord clamping below the perineum in pre-term spontaneous vaginal deliveries.
Detailed description
This study will compare the difference in neonatal hematocrit with delayed cord clamping above vs. below the perineum, in infants who are born via pre-term spontaneous vaginal deliveries that are vigorous at delivery. Delayed cord clamping below the perineum is an accepted clinical practice in obstetrics and gynecology; however, delayed cord clamping above the perineum has not yet been studied in preterm infants. Delayed cord clamping above the perineum will provide the benefit of immediate skin-to-skin contact between the mother and her newborn. Patients will have delayed cord clamping performed for 60-75 seconds either below the maternal perineum or while the infant is placed on the mother's abdomen. At approximately 24 hours after delivery (at the time of infant heel stick for routine, state-mandated screening tests), a small additional amount of blood will be collected to evaluate newborn hematocrit.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Delayed cord clamping above the perineum | After delivery, the infant will be placed on the mother's abdomen and the cord will be clamped 30-45 seconds after delivery of the infant. |
| PROCEDURE | Delayed cord clamping below the perineum | The infant will be held below the perineum, and the cord clamped and cut 60-75 seconds after delivery of the infant. |
Timeline
- Start date
- 2016-01-01
- Primary completion
- 2017-02-01
- Completion
- 2017-02-01
- First posted
- 2016-01-20
- Last updated
- 2022-02-02
- Results posted
- 2022-02-02
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02659605. Inclusion in this directory is not an endorsement.