Nordic Randomized Trial on Laparoscopic Versus Vaginal Cerclage

In the first subsequent viable pregnancy beyond 14+0 weeks of gestation. First prioritized primary outcome.

Loss of a viable pregnancy beyond 14+0 weeks of gestation, miscarriage, stillbirth or death of a live born infant. Second prioritized primary outcome.

Death.

Death.

Admission to ICU or a unit that provides 24-h medical supervision and is able to provide mechanical ventilation or continuous vasoactive drug support.

Admission to ICU or a unit that provides 24-h medical supervision and is able to provide mechanical ventilation or continuous vasoactive drug support.

One or more of the following: Damage to internal organs, need for re-operation, thromboembolic events (defined as deep vein thrombosis, pulmonary embolism or stroke), maternal cardiopulmonary arrest.

One or more of the following: Damage to internal organs, thromboembolic events (defined as deep vein thrombosis, pulmonary embolism or stroke), maternal cardiopulmonary arrest.

Blood loss > 500 ml.

Blood loss > 1000 ml.

Leading to antibiotic treatment, but not ICU.

Leading to antibiotic treatment, but not ICU

Admission to ICU due to serious infection.

Admission to ICU due to serious infection.

Preterm prelabour rupture of membranes, in the first subsequent viable pregnancy beyond 14 weeks of gestation.

Threatened preterm labour requiring admission and intervention, in the first subsequent viable pregnancy beyond 14 weeks of gestation.

Spontaneous labor contractions, PROM, induction of labor, c-section. In the first subsequent viable pregnancy beyond 14 weeks of gestation.

Unassisted vaginal, assisted vaginal (ventouse or forceps), caesarean section (planned, non-planned). In the first subsequent viable pregnancy beyond 14 weeks of gestation.

Death of a liveborn child > 22+0 weeks of gestation.

Death in the 1st 28 days of life > 22+0 weeks of gestation.

Composite of late miscarriage and stillbirth, in the first subsequent viable pregnancy beyond 14 weeks of gestation.

Loss of viable pregnancy between gestational age 14+0-21+6, in the first subsequent viable pregnancy beyond 14 weeks of gestation.

Gestational age at birth, weeks and days, in the first subsequent viable pregnancy beyond 14 weeks of gestation.

Birth before gestational age 28+0, in the first subsequent viable pregnancy beyond 14 weeks of gestation.

Birth before gestational age 34+0, in the first subsequent viable pregnancy beyond 14 weeks of gestation.

Birth before gestational age 37+0, in the first subsequent viable pregnancy beyond 14 weeks of gestation.

Grams. In the first subsequent viable pregnancy beyond 14 weeks of gestation.

Number of consecutive days in hospital within 28 days from time of delivery. In the first subsequent viable pregnancy beyond 14 weeks of gestation.

Any admission counts (SCBU, maternity ward, NICU)

Intraventricular Hemorrhage Grade III and IV and/or Periventricular leukomalacia. In the first subsequent viable pregnancy beyond 14 weeks of gestation.

Retinopathy requiring treatment. In the first subsequent viable pregnancy beyond 14 weeks of gestation.

Necrotizing Enterocolitis (NEC) and/or SIP (Spontaneous intestinal perforation), requiring surgery. In the first subsequent viable pregnancy beyond 14 weeks of gestation.

Mechanical ventilation or non-invasive ventilation. In the first subsequent viable pregnancy beyond 14 weeks of gestation.

Need for surfactant treatment. In the first subsequent viable pregnancy beyond 14 weeks of gestation.

>5 days of i.v. antibiotics, where the treatment commences within the first week of life. In the first subsequent viable pregnancy beyond 14 weeks of gestation.