Dataset Information

Effect of administration routes of oxytocin on hemoglobin in neonates with delayed umbilical cord clamping: a multi-centre randomized controlled clinical trial.

ABSTRACT:

Purpose

To evaluate the effect of intravenous infusion versus intramyometrial injection of oxytocin on hemoglobin levels in neonates with delayed umbilical cord clamping during cesarean section.

Methods

The multi-centre randomized controlled trial was performed at three hospitals from February to June 2023. Women with term singleton gestations scheduled for cesarean delivery were allocated to receive an intravenous infusion of 10 units of oxytocin or a myometrial injection of 10 units of oxytocin during the surgery. The primary outcome was neonatal hemoglobin at 48 to 96 h after birth. Secondary outcomes were side-effects of oxytocin, postpartum haemorrhage, phototherapy for jaundice, feeding at 1 month, maternal and neonatal morbidity and re-admissions.

Results

A total of 360 women were randomized (180 women in each group). The mean neonatal hemoglobin did not show a significant difference between the intravenous infusion group (194.3 ± 21.7 g/L) and the intramyometrial groups (195.2 ± 24.3 g/L) (p = 0.715). Secondary neonatal outcomes, involving phototherapy for jaundice, feeding at 1 month and neonatal intensive care unit admission were similar between the two groups. The maternal outcomes did not differ significantly between the two groups, except for a 200 mL higher intraoperative infusion volume observed in the intravenous group compared to the intramyometrial group.

Conclusion

Among women undergoing elective cesarean delivery of term singleton pregnancies, there was no significant difference in neonatal hemoglobin at 48 to 96 h after birth between infants with delayed cord clamping, whether the oxytocin was administrated by intravenous infusion or intramyometrial injection.

Trial registration

Chinese Clinical trial registry: ChiCTR2300067953 (1 February 2023).

SUBMITTER: Mei L

PROVIDER: S-EPMC11258157 | biostudies-literature | 2024 Aug

REPOSITORIES: biostudies-literature

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Publications

Effect of administration routes of oxytocin on hemoglobin in neonates with delayed umbilical cord clamping: a multi-centre randomized controlled clinical trial.

Mei Lu L Gu Ning N Zhou Yan Y Wang Zhiqun Z Yang Ling L Chen Li L Li Chunxia C Dai Yimin Y

Archives of gynecology and obstetrics 20240516 2

<h4>Purpose</h4>To evaluate the effect of intravenous infusion versus intramyometrial injection of oxytocin on hemoglobin levels in neonates with delayed umbilical cord clamping during cesarean section.<h4>Methods</h4>The multi-centre randomized controlled trial was performed at three hospitals from February to June 2023. Women with term singleton gestations scheduled for cesarean delivery were allocated to receive an intravenous infusion of 10 units of oxytocin or a myometrial injection of 10 u ...[more]

PMID: 38753205

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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: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.

Project description:BackgroundPlacental management strategies such as umbilical cord milking and delayed cord clamping may provide a range of benefits for the newborn. The aim of this review was to assess the effectiveness of umbilical cord milking and delayed cord clamping for the prevention of neonatal hypoglycaemia.MethodsThree databases and five clinical trial registries were systematically reviewed to identify randomised controlled trials comparing umbilical cord milking or delayed cord clamping with control in term and preterm infants. The primary outcome was neonatal hypoglycaemia (study defined). Two independent reviewers conducted screening, data extraction and quality assessment. Quality of the included studies was assessed using the Cochrane Risk of Bias tool (RoB-2). Certainty of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. Meta-analysis using a random effect model was done using Review Manager 5.4. The review was registered prospectively on PROSPERO (CRD42022356553).ResultsData from 71 studies and 14 268 infants were included in this review; 22 (2 537 infants) compared umbilical cord milking with control, and 50 studies (11 731 infants) compared delayed with early cord clamping. For umbilical cord milking there were no data on neonatal hypoglycaemia, and no differences between groups for any of the secondary outcomes. We found no evidence that delayed cord clamping reduced the incidence of hypoglycaemia (6 studies, 444 infants, RR = 0.87, CI: 0.58 to 1.30, p = 0.49, I2 = 0%). Delayed cord clamping was associated with a 27% reduction in neonatal mortality (15 studies, 3 041 infants, RR = 0.73, CI: 0.55 to 0.98, p = 0.03, I2 = 0%). We found no evidence for the effect of delayed cord clamping for any of the other outcomes. The certainty of evidence was low for all outcomes.ConclusionWe found no data for the effectiveness of umbilical cord milking on neonatal hypoglycaemia, and no evidence that delayed cord clamping reduced the incidence of hypoglycaemia, but the certainty of the evidence was low.

Project description:ObjectiveTo evaluate the effect of later cord clamping (LCC) on umbilical arterial blood gas in neonates of diabetic mothers.MethodsThis prospective study included a group of 160 diabetic mothers (DM) whose neonates were randomized to immediate cord clamping (ICC) (≤ 15 s after birth) or LCC (≥ 30 s after birth), and a group of 208 non-diabetic mothers (NDM) whose neonates were randomized to ICC or LCC as a reference. Cord arterial pH, base excess (BE), bicarbonate (HCO3-), partial pressure of carbon dioxide (pCO2), partial pressure of oxygen (pO2), lactate, hemoglobin, hematocrit and glucose were compared among groups.ResultsIn neonates of DM, there was no significant difference in cord arterial pH between the ICC and LCC group. LCC of ≥ 30 s decreased umbilical arterial HCO3- and BE and increased lactate (ICC versus LCC, HCO3-: 24.3 (22.7, 25.8) versus 23.7 (22.3, 24.7) mmol/L, P = 0.01; BE: -2.70 (-4.80, -1.50) versus - 3.72 (-5.66, -2.36) mmol/L, P = 0.006; lactate: 2.1 (1.6, 3.7) versus 2.7 (2.1, 4.3) mmol/L, P = 0.005), without the alterations of pCO2, pO2, hemoglobin, hematocrit and glucose. Similar results were found in neonates of NDM (ICC versus LCC, HCO3-: 24.3 (23.1, 25.7) versus 23.5 (22.3, 24.8) mmol/L, P = 0.01; BE: -2.39 (-3.73, -1.51) versus - 3.40 (-4.73, -1.91) mmol/L, P = 0.001; lactate: 2.2 (1.9, 3.3) versus 2.5 (2.0, 4.3) mmol/L, P = 0.01), except for the higher level of hemoglobin in the LCC group. The majority of diabetic mothers (ICC: 92.0%; LCC: 91.8%) had good blood glucose control. No differences were observed in acid-base status and glucose between neonates of DM and neonates of NDM in both ICC and LCC, but hemoglobin and hematocrit were elevated after ICC in neonates of DM compared to neonates of NDM.ConclusionsLater cord clamping of ≥ 30 s resulted in a tendency towards metabolic acidosis of umbilical arterial blood in neonates of DM and NDM. Umbilical arterial blood gas parameters at birth were similar in neonates of DM and NDM.Trial registrationClinicalTrials.gov: NCT04369313 ; date of registration: 30/04/2020 (retrospectively registered).

Dataset Information

Effect of administration routes of oxytocin on hemoglobin in neonates with delayed umbilical cord clamping: a multi-centre randomized controlled clinical trial.

Purpose

Methods

Results

Conclusion

Trial registration

Publications

Effect of administration routes of oxytocin on hemoglobin in neonates with delayed umbilical cord clamping: a multi-centre randomized controlled clinical trial.

Similar Datasets

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