The timing of umbilical cord clamping has been widely discussed in the scientific community.

As part of the worldwide strategies to reduce childhood iron deficiency anemia, the incorporation of late clamping (at least one minute after delivery), has been adopted as an effective and low-cost measure for health services.

The optimal timing for clamping, ( if until 3 minutes of delivery, or later, when the cord stops spontaneous pulse), still remains controversial.

Also, doubts remain about the effect of late clamping of the umbilical cord on maternal outcomes.

This study has the hypothesis that waiting for the cessation of the cord pulsation will not bring harm to the newborn or the mother.

Due to several studies showing the advantages of late clamping of the umbilical cord for the newborn child. Delayed clamping from one, up to three minutes has been associated with better adaptation of the neonate to extrauterine life, with increased supply of oxygen, iron reserve in childhood, and benefits in the neuropsychic and motor development of children. It is considered a safe technique, recommended and has been recommended by obstetrics and neonatologists throughout the world, although the exact moment for its accomplishment is not aligned between countries.

Early clamping was one of the strategies of active management in the third period of delivery in order to prevent postpartum hemorrahge (PPH), which is considered a major cause of maternal mortality worldwide. Studies have not confirmed this initial hypothesis and the balancing between the advantages for the newborn, and no evidence of advantage fot he mother has shifted the management to late cord clamping, which for most professionals consists of clamping the cord from one to three minutes after birth.

On the other hand, there are still questions regarding the possibility of prolonging the cord clamping time, for an even longer time, or even stopping the cord's pulsations, as a way to favor placental drainage, reduce the time of placental detachment and consequently decrease bleeding events. It is believed that delayed clamping after pulsations cease may contribute to the increase in the blood volume transferred to the neonate, thus increasing its iron stores without any additional harm to the health of the woman and the newborn.

The subject is new, in order to verify the impact on the occurrence of neonatal jaundice and the blood loss when the cord is clamped after the pulsations cease, since there is no detailed report in any other study on this practice. Thus, it can contribute to the available evidence on the subject, and can be included in a systematic review and enable the elucidation of questions that still need to be clarified.

The study is relevant, since the conclusions may be of great use for clinical conduct, since it is a non-invasive and cost-free method that can contribute to reduce the occurrence of iron deficiency anemia in early childhood and postpartum haemorrhage.

General objective To determine the effects of late clamping of the umbilical cord with one to three minutes vs. after pulsations on maternal and neonatal outcomes ceased.

Specific objectives

In neonates and women undergoing delayed clamping with one to three minutes and after ceasing the cord pulsations, compare:

Primary Outcomes Rate of neonatal hyperbilirubinemia, requiring phototherapy is equivalent in both groups.

Neonatal hemoglobin between 24-48 hours postpartum is higher in the intervention group.

Secondary Outcomes Neonatal Weight at birth; Apgar score in the first minute and fifth minute; Skin-to-skin contact in the first hour of life; Duration of skin-to-skin contact; Breastfeeding in the first hour; Breastfeeding until discharge; Concentration of Ht at birth and between 24-48 hours after birth; Need for admission to neonatal neonatal intensive care unit (ICU); Hyperbilirubinemia requiring exchange transfusion; Neonatal polycythemia. Maternal Postpartum blood loss; PPH (blood loss> 1,000ml); Hemoglobin (HG) and (Hematocrit) Ht levels in 24 hours postpartum; Hemoglobin levels lower than 8 g / dl in 24 hours postpartum; Time of detention less than 30 minutes; Uterine manual cleaning, uterine curettage, and manual removal of the placenta; Treatment for PPH in the first hour up to 24 hours postpartum; Hemotransfusion after delivery; Maternal death; Level of maternal satisfaction. Study design=> open randomized clinical trial The study will be conducted in Instituto de Saude Integral Prof Fernando Figueira (IMIP) and Hospital da Mulher do Recife (HMR). Sample will be composed of normal risk women, live fetus at term, hospitalized in labor and by their newborns attended during the study period in the hospitals involved in the research.

Sample size calculation Sample size was based on the primary outcome (neonatal hemoglobin at birth). Assuming a mean hemoglobin concentration of 19.3 g/dL in the physiological clamping group and 19.9 g/dL in the delayed clamping group (standard deviation 2.5 g/dL), 241 participants per group were required to detect this difference with 80% power and a two-sided alpha of 0.05. To account for protocol deviations and potential losses, the target sample size was increased by 20% to 580 women (290 per group).

After consenting to participate a blood sample will be collected from the pregnant woman by the laboratory professional, at the obstetric screening or at the PP, immediately before delivery, and sent to the laboratory for analysis of hemoglobin and hematocrit levels. All participants will be assisted in labor and delivery performed according to the routine of the service. Only after birth, if the newborn meets the eligibility criteria, will the allocation be made to one of the two previously randomized groups, with opening of the sealed envelopes.

Data collection will be performed by the assistant researchers and professionals on duty (nurse obstetrician, obstetrician and / or nursing residents) during the daytime and night shift on weekends and holidays, filling in the 24 hours of the shift. Within 24 hours of delivery, a new blood sample from the puerperium will be collected by the laboratory employee to evaluate hemoglobin and hematocrit levels; and the newborn for evaluation of hemoglobin, hematocrit and total bilirubin levels.

The analysis of the data was performed by intention to treat. Statistical analyses were performed using R (version 4.5.3; R Foundation for Statistical Computing, Vienna, Austria). For the primary outcome (neonatal hyperbilirubinemia requiring phototherapy), non-inferiority was assessed using the difference in proportions with a prespecified non-inferiority margin. For secondary outcomes, continuous variables were compared using Student's t-test or the Mann-Whitney U test as appropriate, and categorical variables were compared using the chi-square test or Fisher's exact test. Relative risks with 95% confidence intervals were calculated for categorical outcomes. A two-sided significance level of 5% was adopted for all comparisons.

Inclusion Criteria:

(pregnant women)

• Low risk pregnancy;
• Full-term pregnancy (37 to 42 weeks);
• Single fetus;
• Cephalic presentation;
• Normal birth;
• Euthocic delivery. (newborns)
• Live birth;
• Apgar> 7 in the first minute and fifth minutes.

Exclusion Criteria:

Early clamping for any reason (indicated by assistant);

• Instrumental delivery (forceps);
• Chorioamnionitis;
• Placental abruption;
• Prolapse of umbilical cord;
• Congenital anomaly;
• Labor analgesia.

No: There is not a plan to make IPD available.