Expectant management or

amnioinfusion for improving

perinatal outcomes
background
PPROM before 26 weeks can delay lung development
and can cause pulmonary hypoplasia .
Pulmonary hypoplasia is a term to describe an altered
pulmonary development
-a reduction in the number of pulmonary alveoli or in
bronchial branching.
In fetal lung development a critical interval, the
canalicular phase, (16 and 28 weeks gestation)
Aims

The primary aim of this study is to evaluate the
effectiveness of amnioinfusion compared to expectant
management
for relieving oligohydramnios in women
midtrimester PPROM < 24 weeks gestational
in reducing perinatal mortality and neonatal
morbidities.
PPROM?
Amnioinfusion
Expectant
Management
Participants/eligibility criteria

A singleton pregnancy who are first diagnosed
between 16 - 24 weeks gestational age
Oligohydramnios secondary to PPROM, at least 72
hours OR < 21 days
Women with oligohydramnios secondary to
iatrogenic PPROM
Exclude categories:
1. Signs of uterine contractions,
(8x uterine contractions/ h)
2. Intrauterine infection
(temperature > 38C plus fetal tachycardia
uterine tenderness
foul/purulent amniotic fluid)
3. A pregnancy complication (hypertension, HELLP syndrome,
preeclampsia etc
4. placental or major structural fetal anomalies
5. signs of cervical incompetence (visible cervical dilatation
/ cervical length of <25 mm
6. signs of fetal distress (abnormal biophysical profile).
Procedures, recruitment, randomisation and
collection of data
sterile speculum examination for visible fluid loss
nitrazine test ( Litmus )
ferning test
to exclude signs of cervical incompetence
(visible dilatation)

ultrasound examination
single deepest pocket (SDP)
Olihohidromnion SDP < 2 cm
to exclude placental and or fetal structural anomalies.
pulmonary hypoplasia - TC/AC or TC/FL
Transabdominal Amnioinfusion

RL
Use of co-intervention

1. Corticosteroids ie Dexamethasone

2. Antibiotics (Erythromycin
orally 250 mg 4 x per day for 10 days).
Study parameters/endpoints

We will compare two groups:

1) Amnioinfusion for midtrimester PPROM with
Oligohydramnios

2) Expectant management for midtrimester PPROM
with oligohydramnios.
primary outcome
-> measure will be perinatal mortality,
intrauterine death
intrapartum death
neonatal death in the first 28 days of life.
Secondary outcomes
Gestational age at delivery
Time from membrane rupture to delivery
Successful amnioinfusion ie SDP > 2cm
Placental abruption
Cord prolapse
Chorioamnionitis
- (fever before or during > 37.5C on 2 occasion > 1h apart />
38.0C
- uterine tenderness (or contractions)
- leucocytosis, maternal/ fetal Tachycardia
- foul-smelling vaginal discharge

Fetal trauma due to puncture.
Maternal length of stay in hospital.
Neonatal endpoints
Lethal pulmonary hypoplasia
Non-lethal pulmonary hypoplasia
Survival till discharge from NICU.
Chronic lung disease (CLD) oxygen dependency at 28
days of life
Number of days on ventilatory support.
Length of stay in hospital.
Necrotising enterocolitis (NEC) (infant bowel disorder)
Periventricular leukomalacia (PVL) > gradeI
Severe intraventricular hemorrhage (IVH) >grade II
Proven neonatal sepsis + blood culture taken at birth
within 72 hours >2 symptoms of infection
An adverse event (AE)
an event afterwhich the intervention has to be
stopped.

Reasons for discontinuation ;
-placental abruption
- cord prolapse,chorioamnionitis
- -fetal loss, fetal trauma due to puncture
- -premature labour and delivery.
Sample size calculation

A sample size calculation was based on an expected rate of
perinatal mortality of 70% with expectant management to
be reduced to 35% with amnioinfusion.
0
10
20
30
40
50
60
70
80
Discussion

Insufficient evidence to recommend this procedure
Small sample size

The benefits might be increased neonatal survival and
decreased pulmonary complications esp pulmonary
hypoplasia.

Potential harms include
-placental abruption, premature
-labour and delivery
- cord prolapse
- -chorioamnionitis,
- fetal loss, fetal trauma due to puncture.

Expectant management indeed carries these same risks
Conclusion
At present, there is no evidence on
which a rational choice between
expectant management or therapeutic
amnioifusion can be based.
Thank you