Dataset Information

Effect of delayed versus immediate umbilical cord clamping in vaginal delivery at term: A randomized clinical trial.

ABSTRACT:

Objective

To compare maternal blood loss with immediate cord clamping versus delayed cord clamping in women undergoing spontaneous vaginal delivery at term.

Methods

Parallel group non-blinded randomized trial conducted at a single center in Italy. Women with singleton gestations who underwent spontaneous vaginal delivery at term were eligible and were randomized in a 1:1 ratio to either immediate or delayed cord clamping. In the immediate cord clamping group, cord clamping was within 15 s after birth. In the delayed cord clamping group, cord clamping was after more than 60 s, or when the cord had stopped pulsing. The primary outcome was change in maternal hemoglobin level from the day of delivery to day one after delivery.

Results

A total of 122 participants were enrolled in the trial. There were no significant differences in maternal blood loss as assessed by comparing the decrease in maternal hemoglobin level (mean difference - 0.10 g/dl, 95% confidence interval - 0.28 to 0.08) between the two groups. The mean hemoglobin level at postdelivery day 1 was 11.0 ± 1.5 g/dl in the delayed group and 11.3 ± 1.6 g/dl in the immediate group.

Conclusions

Delayed umbilical cord clamping, compared with immediate umbilical cord clamping, resulted in no significant change in maternal hemoglobin level 1 day after delivery.

Trial registration

Clinicaltrials.gov NCT04353544.

SUBMITTER: De Angelis C

PROVIDER: S-EPMC9790594 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effect of delayed versus immediate umbilical cord clamping in vaginal delivery at term: A randomized clinical trial.

De Angelis Carlo C Saccone Gabriele G Sorichetti Elisa E Alagna Maurizio M Zizolfi Brunella B Gragnano Elisabetta E Legnante Antonietta A Sardo Attilio Di Spiezio ADS

International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics 20220502 3

<h4>Objective</h4>To compare maternal blood loss with immediate cord clamping versus delayed cord clamping in women undergoing spontaneous vaginal delivery at term.<h4>Methods</h4>Parallel group non-blinded randomized trial conducted at a single center in Italy. Women with singleton gestations who underwent spontaneous vaginal delivery at term were eligible and were randomized in a 1:1 ratio to either immediate or delayed cord clamping. In the immediate cord clamping group, cord clamping was wit ...[more]

PMID: 35428979

Similar Datasets

Project description:ImportanceThe American College of Obstetricians and Gynecologists recommends a delay in umbilical cord clamping in term neonates for at least 30 to 60 seconds after birth. Most literature supporting this practice is from low-risk vaginal deliveries. There are no published data specific to cesarean delivery.ObjectiveTo compare maternal blood loss with immediate cord clamping vs delayed cord clamping in scheduled cesarean deliveries at term (≥37 weeks).Design, setting, and participantsRandomized clinical trial performed at 2 hospitals within a tertiary academic medical center in New York City from October 2017 to February 2018 (follow-up completed March 15, 2018). A total of 113 women undergoing scheduled cesarean delivery of term singleton gestations were included.InterventionsIn the immediate cord clamping group (n = 56), cord clamping was within 15 seconds after birth. In the delayed cord clamping group (n = 57), cord clamping was at 60 seconds after birth.Main outcomes and measuresThe primary outcome was change in maternal hemoglobin level from preoperative to postoperative day 1, which was used as a proxy for maternal blood loss. Secondary outcomes included neonatal hemoglobin level at 24 to 72 hours of life.ResultsAll of the 113 women who were randomized (mean [SD] age, 32.6 [5.2] years) completed the trial. The mean preoperative hemoglobin level was 12.0 g/dL in the delayed and 11.6 g/dL in the immediate cord clamping group. The mean postoperative day 1 hemoglobin level was 10.1 g/dL in the delayed group and 9.8 g/dL in the immediate group. There was no significant difference in the primary outcome, with a mean hemoglobin change of -1.90 g/dL (95% CI, -2.14 to -1.66) and -1.78 g/dL (95% CI, -2.03 to -1.54) in the delayed and immediate cord clamping groups, respectively (mean difference, 0.12 g/dL [95% CI, -0.22 to 0.46]; P = .49). Of 19 prespecified secondary outcomes analyzed, 15 showed no significant difference. The mean neonatal hemoglobin level, available for 90 neonates (79.6%), was significantly higher with delayed (18.1 g/dL [95% CI, 17.4 to 18.8]) compared with immediate (16.4 g/dL [95% CI, 15.9 to 17.0]) cord clamping (mean difference, 1.67 g/dL [95% CI, 0.75 to 2.59]; P < .001). There was 1 unplanned hysterectomy in each group.Conclusions and relevanceAmong women undergoing scheduled cesarean delivery of term singleton pregnancies, delayed umbilical cord clamping, compared with immediate cord clamping, resulted in no significant difference in the change in maternal hemoglobin level at postoperative day 1.Trial registrationClinicalTrials.gov Identifier: NCT03150641.

Project description:BackgroundDelayed cord clamping (DCC) is a placental to new-born transfusion strategy recommended by obstetric and gynaecological societies. Though not widely adopted, umbilical cord milking (UCM) may achieve faster transfusion when DCC cannot be performed such as when a neonate requires resuscitation.MethodsPragmatic, two-arm, randomized clinical trial in which consenting women in spontaneous labour or provider-initiated delivery at 28 to less than 37 weeks at Kenyatta National Hospital in Nairobi, Kenya, were enrolled. At delivery, stable preterm infants were randomized to UCM (4 times) or DCC (60 seconds). Neonatal samples were collected for analysis at 24 hours after delivery. Maternal primary PPH (within 24 hours) and neonatal jaundice (within 1 week) were evaluated clinically. The primary outcome was the mean neonatal haemoglobin level at 24 hours after birth. Modified Intention to treat analysis was used for all outcomes. P-value was significant at p<0.05.ResultsBetween March 2018 to March 2019, 344 pregnant women underwent screening, and 280 eligible participants were randomized when delivery was imminent. The intervention was not performed on 19 ineligible neonates. Of the remaining 260 neonates, 133 underwent UCM while 128 underwent DCC. Maternal and neonatal baseline characteristics were similar. The mean neonatal haemoglobin (17.1 vs 17.5 grams per decilitre, p = 0.191), haematocrit (49.6% vs 50.3%, p = 0.362), anaemia (9.8% vs 11.7%, p = 0.627), maternal PPH (2.3% vs 3.1%, p = 0.719) were similar between UCM and DCC respectfully. However, neonatal polycythaemia (2.3% vs 8.6%, p = 0.024) and neonatal jaundice (6.8% vs 15.6%, p = 0.024) were statistically significantly lower in UCM compared to DCC.ConclusionUCM compared to DCC for preterm neonates resulted in similar outcomes for neonatal haemoglobin, haematocrit, anaemia and maternal primary PPH and a lower proportion of neonatal polycythaemia and clinical jaundice. UCM offers a comparable method of placental transfusion compared to DCC and may be considered as an alternative to DCC in preterm neonates at 28 to <37 weeks' gestation.

Project description:AimTo explore delivery care staff's perceptions and attitudes towards changes in practice of umbilical cord clamping in order to identify work culture barriers and enablers for improved clinical practice and implementation of the new guidelines on cord clamping.MethodA purposive sampling strategy was used to include delivery staff at two major hospitals in Kathmandu, Nepal for focus group discussions. Key informant interviews were conducted with the ward in-charges and skilled birth attendant trainers at the respective hospitals. Data were analyzed using qualitative content analysis.ResultEight focus group discussions altogether with 34 delivery care staff working in the labor room and birthing units, and 12 key informant interviews with skilled birth attendant trainers/supervisors and ward in-charges from both hospitals participated in the study. Participants had positive attitudes towards delayed cord clamping as it was not perceived to be a difficult task and as they perceived it to be beneficial for mother and child. The "will to do good", and a high level of trust both in the hierarchical system as well as in scientific evidence were identified as promoters of change. Several barriers were mentioned, such as maternal or fetal medical conditions and physical settings, as constraints to perform delayed cord clamping. They also mentioned difficulties in adopting new guidelines due to habitual practice, lack of formal training and poor coherence within the work team. In order to bring change to the practice, participants highlighted that officially approved national and institutional protocols and regular training are crucial.ConclusionDue to poor coherence within the health system and lack of national or institutional protocols, delivery staff has to rely on their own initiative to develop skills and are left to informal decision making, and are therefore hesitant to apply new routines. In order to change cord clamping practices to align with evidence and policies health-care staff needs to be better supported by the governance structures of the health system, with clear and approved guidelines made available and coherent training and support.

Project description:ImportanceUmbilical cord milking as an alternative to delayed umbilical cord clamping may provide equivalent benefits to preterm infants, but without delaying resuscitation.ObjectiveTo determine whether the rates of death or severe intraventricular hemorrhage differ among preterm infants receiving placental transfusion with umbilical cord milking vs delayed umbilical cord clamping.Design, setting, and participantsNoninferiority randomized clinical trial of preterm infants (born at 23-31 weeks' gestation) from 9 university and private medical centers in 4 countries were recruited and enrolled between June 2017 and September 2018. Planned enrollment was 750 per group. However, a safety signal comprising an imbalance in the number of severe intraventricular hemorrhage events by study group was observed at the first interim analysis; enrollment was stopped based on recommendations from the data and safety monitoring board. The planned noninferiority analysis could not be conducted and a post hoc comparison was performed instead. Final date of follow-up was December 2018.InterventionsParticipants were randomized to umbilical cord milking (n = 236) or delayed umbilical cord clamping (n = 238).Main outcomes and measuresThe primary outcome was a composite of death or severe intraventricular hemorrhage to determine noninferiority of umbilical cord milking with a 1% noninferiority margin.ResultsAmong 540 infants randomized, 474 (88%) were enrolled and completed the trial (mean gestational age of 28 weeks; 46% female). Twelve percent (29/236) of the umbilical cord milking group died or developed severe intraventricular hemorrhage compared with 8% (20/238) of the delayed umbilical cord clamping group (risk difference, 4% [95% CI, -2% to 9%]; P = .16). Although there was no statistically significant difference in death, severe intraventricular hemorrhage was statistically significantly higher in the umbilical cord milking group than in the delayed umbilical cord clamping group (8% [20/236] vs 3% [8/238], respectively; risk difference, 5% [95% CI, 1% to 9%]; P = .02). The test for interaction between gestational age strata and treatment group was significant for severe intraventricular hemorrhage only (P = .003); among infants born at 23 to 27 weeks' gestation, severe intraventricular hemorrhage was statistically significantly higher with umbilical cord milking than with delayed umbilical cord clamping (22% [20/93] vs 6% [5/89], respectively; risk difference, 16% [95% CI, 6% to 26%]; P = .002).Conclusions and relevanceIn this post hoc analysis of a prematurely terminated randomized clinical trial of umbilical cord milking vs delayed umbilical cord clamping among preterm infants born at less than 32 weeks' gestation, there was no statistically significant difference in the rate of a composite outcome of death or severe intraventricular hemorrhage, but there was a statistically significantly higher rate of severe intraventricular hemorrhage in the umbilical cord milking group. The early study termination and resulting post hoc nature of the analyses preclude definitive conclusions.Trial registrationClinicalTrials.gov Identifier: NCT03019367.

Dataset Information

Effect of delayed versus immediate umbilical cord clamping in vaginal delivery at term: A randomized clinical trial.

Objective

Methods

Results

Conclusions

Trial registration

Publications

Effect of delayed versus immediate umbilical cord clamping in vaginal delivery at term: A randomized clinical trial.

Similar Datasets

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