N/A
N=74
Cord Clamping Level Above or Below Mother's Perineum
Pre-term Birth · Delayed Cord Clamping
Bottom Line
View on ClinicalTrials.gov: NCT02659605 ↗Enrolled (actual)
74
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcome: Primary: Hematocrit Level — 51.5; 52.6 % of blood composed of red blood cells — p=0.572
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Delayed cord clamping above the perineum (Procedure); Delayed cord clamping below the perineum (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hematocrit Level |
51.5; 52.6 | 0.572 |
| SECONDARY Number of Participants With Infants Who Were Admitted to the Neonatal Intensive Care Unit (NICU) |
21; 21 | 0.849 |
| SECONDARY Number of Participants With Infants Who Received Phototherapy |
14; 13 | 0.886 |
| SECONDARY Number of Participants With Infants Who Received Blood Transfusion |
1; 2 | 0.612 |
| SECONDARY Apgar Score at 1 Minute |
7.8; 7.9 | 0.728 |
| SECONDARY Apgar Score at 5 Minutes |
8.7; 8.6 | 0.584 |
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.
Eligibility Criteria
Inclusion Criteria
- Singleton intrauterine pregnancies at least 30 weeks gestation but less than 37 weeks gestation
Exclusion Criteria
- Acute febrile illnesses or chronic medical problems such as hypertension, diabetes mellitus, renal disease, medically-managed seizure disorders
- Pregnancy-related complications such as pre-eclampsia, intrauterine growth restriction, chromosomal/anatomical abnormalities, and placental abruption
- Infants who are not anticipated to undergo spontaneous vaginal delivery
Data sourced from ClinicalTrials.gov (NCT02659605). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.