Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00007117

Trial Description

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Title

The Charité Cesarean Birth - A Family and Partner Orientated Approach of Cesarean Section“

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Trial Acronym

CCB

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URL of the Trial

http://nicht vorhanden

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Brief Summary in Lay Language

There is a constant raise in Cesarean Section (CS) rates worldwide. For example in Europe the
rate is about 30%. The indications for CS are varied and include not only clear medical
indications but there are also psychological, social and medico legal aspects which influence the
decision to perform a CS. Nonetheless the procedure was not modified in terms of an active
integration of the parents in the birth process. Research focus was on technical aspects and
complications of a CS. In many hospitals, it is routine practice within CS that the newborn is
taken by a midwife or neonatologist immediately after cutting of the umbilical cord, the baby is
then examined before being introduced to the parents, often several minutes after the birth. Also
there is a drape lift up so that the parents do not directly see the baby. Compared to a vaginal
delivery, the baby is not given directly onto the mother to promote early skin-to-skin contact. This
positively affects breast feeding and leads to better mother infant interaction. It also reduces
crying and stabilizes the newborn. This present study evaluated a modification of the CS, which
includes the following: The surgical technique of the CS is not different. When the baby is lift out
of the abdomen, the drape will be lowered. The "lift out" of the baby is visible for the parents and
is slower for a better adaption. The Babies belly compresses the "scar" so there is no blood
visible and no view into the surgical area. Then the attending partner can cut the umbilical cord. If
the cardiorespiratory adaption is adequate the newborn will be directly taken onto the naked skin
of the mother’s breast and stay there until the end of the operation. The screen is then lift up
again. After four days patients birth experience was examined and also success rates and
problems with breast-feeding where evaluated. Also the safety of the procedure itself was
measured. The procedure was established at the Charité University Hospital Berlin and therefore
named "Charité Cesarean Birth".

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Brief Summary in Scientific Language

There is a constant raise in Cesarean Section (CS) rates worldwide. For example in Europe the
rate is about 30%. The indications for CS are varied and include not only clear medical
indications but there are also psychological, social and medico legal aspects which influence the
decision to perform a CS. Nonetheless the procedure was not modified in terms of an active
integration of the parents in the birth process. Research focus was on technical aspects and
complications of a CS. In many hospitals, it is routine practice within CS that the newborn is
taken by a midwife or neonatologist immediately after cutting of the umbilical cord, the baby is
then examined before being introduced to the parents, often several minutes after the birth. Also
there is a drape lift up so that the parents do not directly see the baby. Compared to a vaginal
delivery, the baby is not given directly onto the mother to promote early skin-to-skin contact. This
positively affects breast feeding and leads to better mother infant interaction. It also reduces
crying and stabilizes the newborn. This present study evaluated a modification of the CS, which
includes the following: The surgical technique of the CS is not different. When the baby is lift out
of the abdomen, the drape will be lowered. The "lift out" of the baby is visible for the parents and
is slower for a better adaption. The Babies belly compresses the "scar" so there is no blood
visible and no view into the surgical area. Then the attending partner can cut the umbilical cord. If
the cardiorespiratory adaption is adequate the newborn will be directly taken onto the naked skin
of the mother’s breast and stay there until the end of the operation. The screen is then lift up
again. After four days patients birth experience was examined and also success rates and
problems with breast-feeding where evaluated. Also the safety of the procedure itself was
measured. The procedure was established at the Charité University Hospital Berlin and therefore
named "Charité Cesarean Birth".

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Organizational Data

  •   DRKS00007117
  •   2014/11/05
  •   [---]*
  •   yes
  •   Approved
  •   EA2/112/13, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Patients with a need for a primary planned cesarean section
  •   O82 -  Single delivery by caesarean section
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Interventions/Observational Groups

  •   Group “Charité Cesarean Birth” and can be described as follows:
    Phase 1: First, routine epidural anaesthesia is performed and sterile preparation is carried out. Then the surgery starts with the surgical drape screen up. The Misgav-Ladach technique is used to open the abdomen. The Operation Theatre is warmed and the lights are dimmed, also the staff is pleased to stay relatively quiet during the operation.
    Phase 2: Shortly before the uterine incision patients are again asked if they are in agreement to continue with the procedure. After the uterotomy, the surgeon lifts the head of the baby out of the uterus. Then the surgical drape is lowered. It is also possible to lower the screen before the lifting out of the head. This procedure will only be performed if no complications occurred during the operation and this remains an individual decision by the surgeon. In the event of unexpected complications like heavy bleeding or problems with the lift out of the babies head the surgical drape will not be lowered. During the antenatal counselling patients were informed in detail about the steps of the procedure.
    The principle is then to slowly “walk” the baby out. This step should be visible for the parents. It is also possible for the patient try to “actively push”. In contrast to the classical rapid removal of the newborn, this technique allows pressure from the uterus and other tissues to expel lung liquid. There is no need to actively take out the baby. The trunk of the newborn compresses the uterotomy. Hence a view into the opened abdomen for the mother and father or partner is not possible. Afterwards, the umbilical cord is clamped. Now the father or partner receives a pair of sterile scissors from the surgeon and then cuts the umbilical cord. The newborn is then examined by the surgeon and not by the midwife or neonatologist for fetal well being. If this is adequate, the newborn will be directly taken onto the naked skin of the mother’s breast. The baby is covered by a warm towel and is constantly observed by the midwife. The child will be monitored according the Apgar score. Phase 3: After giving the baby to the mother the uterus in manually checked for residual tissues. Then routine closure of uterus and abdominal wall.
  •   Conventional CS. Technique according to the Misgav-Ladach CS.
    After lift out of the baby and cutting the umbilical cord by the surgeon it is taken to the neonatologist for primary examination. When the operation has ended the baby will be given to the parents.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   data analyst
  •   Active control
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

1. Perinatal safety: APGAR Scores. Admission to an intensive care unit. Cardiorespiratory
problems. Blood gas analysis umbilical cord (arterial pH value). Satisfaction with birth
2. Mothers safety: cardiorespiratory disorders. Blood loss.
Modified Likert Scales were used to assess parameters of birth experience/satisfaction. Patients were asked with a standardized questionnaire between the second and fourth day after surgery.

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Secondary Outcome

1. Success rates of breast feeding.
2. Problems with breast feeding.
3. Conception of early-skin-to-skin contact.
4. Complications of the attending partner.
Again Likert Scales were used. Also standardized questionnaire, given between 2nd and 4th day after birth.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/01/01
  •   200
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   50   Years
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Additional Inclusion Criteria

1. Age >18 years and fulfilling all criteria for a medically indicated need for CS. The indications
are according to the guidelines of the German Society for Gynaecology and Obstetrics.
2. Willing to be assigned to any of the study intervention groups
3. Gestational age >37 weeks, patients without history of heavy peripartal bleeding, bleeding
disorders or other severe known maternal morbidities and known fetal anomalies.

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Exclusion Criteria

1. preoperative change of consent from the parents
2. heavy bleeding or other unexpected complications during CS and mechanical difficulty with the
lift out of the babies head or breech.
3. All fetuses with prenatal diagnosed anomalies which required an immediate treatment were
excluded (e.g. relevant congenital heart anomalies, closing defects of the abdominal wall,
diaphragmatic hernia).
4. patients without written informed consent.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Geburtsmedizin der Charité
    • Mr.  Dr. med.  Robert  Armbrust 
    • Augustenburger Platz 1
    • 13352  Berlin
    • Germany
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  • start of 1:1-Block address scientific-contact
    • Klinik für Geburtsmedizin der Charité
    • Mr.  Dr. med.  Robert  Armbrust 
    • Augustenburger Platz 1
    • 13352  Berlin
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Klinik für Geburtsmedizin der Charité
    • Mr.  Dr. med.  Robert  Armbrust 
    • Augustenburger Platz 1
    • 13352  Berlin
    • Germany
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    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Klinik für Geburtsmedizin der Charité
    • Mr.  Dr. med.  Robert  Armbrust 
    • Augustenburger Platz 1
    • 13352  Berlin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
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Status

  •   Recruiting complete, follow-up complete
  •   2014/10/01
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Trial Publications, Results and other Documents

  • [---]*
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* This entry means the parameter is not applicable or has not been set.