Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Double-blinded Randomized Controlled Trial With Indomethacin Versus Placebo in Women With Preterm Premature Rupture of Membranes (PPROM) Between 24 and 32 Weeks Gestation
Brief Summary: The purpose of this study is to determine if the short term use of indomethacin will reduce the number of women delivering within 48 hours when given to women with preterm premature rupture of membranes (PPROM) between 24- 32 weeks of gestation. We hypothesize that indomethacin's anti-inflammatory and tocolytic action will reduce the number of women delivering within 48 hours when given to women with PPROM between 24-32 weeks of gestation.


Options:
A: Inclusion Criteria:

* Gestational age between 24 0/7 - 31 5/7 weeks by LMP or ultrasound
* Documentation of rupture by demonstrating pooling or 2/3 diagnostic tests (pooling, ferning and nitrazine positivity)

Exclusion Criteria:

* Membrane rupture greater than 72 hours
* Persistent labor characterized by regular painful contractions with cervical change and/or cervix visually greater than 5 cm
* Chorioamnionitis defined by having 2 or more of the following: maternal temperature \> 100.4, persistent fetal tachycardia (\>170bpm), maternal tachycardia (\>110bpm) in the absence of other likely cause, uterine tenderness.
* Non-reassuring fetal heart rate tracing or biophysical testing
* Vaginal hemorrhage
* Lethal fetal anomalies
* Intrauterine fetal demise
* Maternal conditions which precludes expectant management
* Fetal condition which precludes expectant management
* Maternal allergy to indomethacin
* Maternal active gastritis
* Multiple gestations
* HIV with viral load \>1000
* HSV with active herpetic lesions
* Cervical cerclage
B: Inclusion Criteria:

* We will include pregnant women between 22 0/7 to 31 6/7 weeks gestation who present with regular uterine contractions defined as at least one contraction every 10 minutes for 30 minutes with at least one of the following:
* cervical change of at least 1 cm or
* cervical dilation of 2 cm at the time of initial exam or
* positive fetal fibronectin and transvaginal cervical length \<2.5 cm

Exclusion Criteria:

* We will exclude pregnant women with any contraindication to tocolysis:
* clinical chorioamnionitis (defined as a temperature of \>100.4 F and any of the following: fundal tenderness, maternal tachycardia, fetal tachycardia or purulent vaginal discharge)
* non reassuring fetal heart tones
* suspected placental abruption
* preterm premature rupture of membranes
* prior tocolytic treatment during the past 48 hours
* known adverse effect to indomethacin or nifedipine
* already receiving nifedipine for chronic hypertension
C: Inclusion Criteria:

1. Twin pregnancy
2. Gestational age between 24+0 and 32+6 weeks
3. Intact amniotic membranes
4. Threatened preterm labor
5. Age 18-50.

Exclusion Criteria:

1. Rupture of membranes
2. Vaginal bleeding resulting from placenta previa or placental abruption
3. Fever above 38°C
4. Severe preeclampsia
5. Maternal cardiovascular or liver diseases
6. Systolic blood pressure less than 90 mm Hg
7. Known uterine malformation
8. Intrauterine growth restriction below the fifth percentile
9. Non-reassuring fetal status
10. Antepartum diagnosis of major fetal malformations
11. Fetal death
12. Previous tocolytic therapy or Betamethasone treatment
D: Inclusion Criteria:

* Preterm premature rupture of membranes (PPROM) between 220/7 - 336/7 weeks of gestation, as diagnosed by obstetric team
* Singleton gestation
* Fetus alive at the time of randomization (reassuring fetal heart monitoring)
* 18 years of age or older
* French speaking
* Affiliated to social security regime or an equivalent system
* Informed consent and signed

Exclusion Criteria:

* PPROM ≥ 24 hours before diagnosis
* Ongoing tocolytic treatment at the time of PPROM
* Tocolytic treatment with Nifedipine between PPROM diagnosis and randomization
* Fetal condition contraindicating expectant management including chorioamnionitis, placental abruption, intrauterine fetal demise, non-reassuring fetal heart rate at the time of randomization
* Cervical dilation \> 5 cm
* Iatrogenic rupture caused by amniocentesis or trophoblast biopsy
* Major fetal anomaly
* Maternal allergy or contra-indication to Nifedipine or placebo drug components\*:

  * Myocardial infarction
  * Unstable angina pectoris
  * Hepatic insufficiency
  * Cardiovascular shock
  * Beta blockers

placebo drug components: lactose monohydrate, colloidal silica, microcrystalline cellulose

* Coadministration of diltiazem or rifampicin
* Hypotension (systolic pressure \< 90 mmHg)
* Participation to another interventional research (category 1) in which intervention could interfere with TOCOPROM's results (efficacy and safety)

Answer: A